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WARNING LETTER
CMS # 677524

March 18, 2024

Dear Mr. Lin:

During an inspection of your firm, Sol-Millennium Medical, Inc., located at 311 S Wacker Drive, Suite 4100, Chicago, IL 60606-6604 on December 14, 2023, through December 20, 2023, investigators from the United States Food and Drug Administration (FDA) determined that your firm is a Specification Developer, Initial Importer, and a Complaint File Establishment of sterile and non-sterile syringes and needles intended for aspiration and injection of medications and fluids into the body. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.

We received responses from you dated January 12, 2024, and January 29, 2024 concerning our investigator(s)’ observations noted on the FDA Form 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. We address these responses below, in relation to each of the noted violations, and any additional responses will be reviewed as part of your warning letter response.

Unapproved Device Violations

Our inspection revealed that the devices listed in Table 1 below are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g). The devices are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction into interstate commerce for commercial distribution these devices with (1) major changes or modifications to the intended use, and/or (2) a change or modification in the device that could significantly affect the safety or effectiveness of the device without submitting a premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a)(3)(i)-(ii).

Specifically, during our inspection you provided “EXH 039 - NACA PRODUCT LIST W 510K AND VENDORS_REVISED 15DEC2023.XLSX”. This document provides information related to the item number, product line, item description, whether the product is active, if Sol-M is the legal manufacturer, the PML 510k number and the prime manufacturer. Within this document you have listed product lines as covered by K101359. FDA’s investigation revealed that several of these product lines were not included under the clearance conditions established in K101359. The Inviro Medical Luer Lock Syringe was cleared under K101359 with the following indications for use: The InviroStripe Standard Luer Lock Syringes are used to inject medicines and vaccines into, or withdraw fluids from, the body. The FDA clearance for K101359 was based on a review of the 1, 3, 5, 10, 20, 30 and 60 mL Standard Luer Lock Syringes and the 510(k) Summary notes in the Device Description section that the syringes are packaged without needles. However, your firm’s promotion of the InviroStripe Standard Luer Lock Syringes provides evidence that you are marketing syringes with substantially different technological characteristics, namely luer lock syringes with blunt fill needles, luer lock syringes with pre-staked safety needles, luer lock syringes with exchangeable hypodermic needles, luer slip syringes, and eccentric tip syringes. Each of these different technological characteristics = constitutes a significant change or modification in design that could significantly alter the safety and effectiveness of the InviroStripe Standard Luer Lock Syringe without submitting a 510(k) to FDA. Specifically, switching from a luer lock to a luer slip or eccentric syringe tip, and including a new component such as a needle could result in the risk of patient harm such as inaccurate dosing, a leaking device, contamination, and a higher risk of inappropriate needle detachment. Changing the configuration of a syringe to include a needle without assurance of FDA review that this change was appropriately verified and validated could also lead to adverse health effects such as allergic reactions, skin irritation or inflammation, pain, fever, red blood cell damage that induces organ stress, and toxicity that leads to loss of organ function or failure.

Your firm’s promotion of the InviroStripe Standard Luer Lock Syringe also provides evidence that you are marketing devices with a substantially different intended use under K101359, including syringes with a low dead space claim as well as accessories to syringes (see Table 1). These changes constitute a major change or modification to the device’s intended use, for which your firm lacks clearance or approval. Specifically, unsupported low dead space claims can result in patient harm such as dose inaccuracy and misleading users about the risk of disease transmission while using the device. Accessories such as those in Table 1 are not intended for withdrawal from or injection into the body, but are devices intended for use with syringes. Unsupported accessory device claims may lead to patient harm by increasing the existing risks of syringes when used together, including breakage, leaking, contamination, and dose inaccuracy.

Your firm’s failure to submit 510(k)s for these devices has prevented FDA from evaluating the risks posed by these substantially different technological characteristics or from determining that these modified devices are as safe and effective as legally marketed syringes. Further, FDA has observed evidence of postmarket safety signals indicating product quality issues that have the potential to cause serious patient harm. Specifically, FDA is aware of multiple customer complaints regarding quality issues (e.g., cracks, breakage, luer connectivity failure, etc.) for syringes marketed by your firm.

For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency (21 CFR 807.81(b)). The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.

The adequacy of your firm’s response cannot be determined at this time. Your January 29, 2024, response indicates that you will file a new 510(k) with FDA to obtain a valid 510(k) clearance. You note that your firm will conduct and submit testing as part of the new 510(k) submission and have included a list of tests, based on the current version of the standards, that will be completed to support these changes. We cannot determine the adequacy of your firm’s response concerning the addition of the luer lock syringes with blunt fill needles, luer lock syringes with pre-staked safety needles, luer lock syringes with exchangeable hypodermic needles, luer slip syringes, eccentric tip syringes, dead space syringes, and syringe accessories because the results of this testing have not been provided.

Table 1 List of Sol-Millennium Medical Inc. piston syringes configurations implicated in this Warning Letter.

Registration & Listing Violations

Under section 510 of the Act (21 U.S.C. § 360), manufacturers of medical devices are required to annually register with the FDA. Section 510 of the Act further requires domestic and foreign device establishments to submit their annual establishment registration and device listing information to FDA by electronic means [section 510(p) of the Act (21 U.S.C. § 360(p))] during the period beginning October 1st and ending December 31st of each year. Our records indicate that your firm has not fulfilled annual registration and listing requirements for fiscal year 2024.

Our inspection revealed that your firm registered its Suwanee, Georgia site and listed activities as a Complaint File Establishment (CFE), Initial Importer, and Specification Developer (SPD) for your medical devices, including devices listed in Table 1 above. However, it was discovered that your firm moved its global headquarters, including complaint handling activities, from Suwanee, GA to Chicago, IL in September 2020. It was also determined that your firm conducts design (specification development) activities at your Lugano, Switzerland and Shanghai, China sites. At the time of the inspection, these three facilities engaged in the manufacture of your devices were not registered with FDA, nor were any of your firm’s devices listed with their respective manufacturing facilities. During the inspection, your Quality Consultant explained that your firm thought it was acceptable to register and list your devices under the Suwanee, GA site since you maintain an office there for the purpose of receiving mail and accessing electronic records. Under 21 C.F.R. 807.20(a), an establishment “engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of a device intended for human use shall register and submit listing information for those devices in commercial distribution”. The same is required for foreign device establishments under section 510(j)(1) (21 U.S.C. 360(j)(1)) and 21 CFR 807.40(a). To date, FDA has not received any response from your firm regarding our investigator(s)’ observations regarding registration.

Therefore, all of your firm’s devices are misbranded within the meaning of section 502(o) of the Act (21 U.S.C. § 352(o)), in that the devices were not included in a list required by section 510(j) of the Act (21 U.S.C. § 360(j)).

Additionally, it was also revealed during our inspection that your firm is still shipping product with addresses of the former headquarter locations in Lawrenceville, GA and Suwanee, GA. Under section 502(b) of the Act (21 U.S.C. § 352(b)) device labels are required to contain “the name and place of business of the manufacturer, packer, or distributer.” Under 21 CFR 801.1(e) you may list your principal place of business on the label rather than the actual location of manufacturing, packing, or distribution. To date, FDA has not received any response from your firm regarding our investigator(s)’ observations regarding address labeling. Therefore, because the Lawrenceville and Suwanee sites are neither the actual location of manufacturing, packing, or distribution and because neither is your principal place of business, any devices which bear these locations on the label are misbranded under section 502(b) of the Act.

Quality System Regulation Violations

This inspection also revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at 21 CFR Part 820. These violations include, but are not limited to, the following:

1. Failure to establish and maintain procedures for the identification, documentation, validation, or where appropriate verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i).

Specifically, your firm has not applied the requirements of the Medical Device Development Manual, GOP-0011, Rev 7 (Oct-30-2023), Section 9.5 and the Engineering Change Request (ECR) and Engineering Change Order (ECO) Procedure, GOP-0018, Rev 6 (Sep-30-2023), to control the design changes before their implementation to your syringe devices. For example, there is no documentation, including, but not limited to, ECRs for the following activities of marketed devices:

a. The change to combine the Sol-M Luer Lock Syringe with Blunt Fill Needle covered under K101359.

b. The change to add a hypodermic and safety needle to the Luer Lock Syringe covered under K101359.

c. The change to add 23, 30, and 31G needles to insulin and TB syringes covered under K132681.

The adequacy of your firm’s responses cannot be determined at this time. Your January 29, 2024, response indicated that you created ECR-2024-003 covering products concerning Item 1a above, ECR-2024-004 covering products concerning Item 1b above, and ECR-2024-005 covering products concerning Item 1c above. However, documentation or evidence of completed corrective actions was not provided, including corrective actions conducted as a result of your investigation into the root-cause(s) associated with the failure to implement your design change control procedures, and verification and/or validation that the corrective actions were effective, prior to their implementation, to prevent recurrence of these violations, as indicated in the Global Quality Manual, GQM-0001, Rev. 18 (Oct-11-2023), Section 7.5.1.

2. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). Specifically,

a. Your firm did not initiate a complaint file for User Report MW511832 after being notified by FDA on June 16, 2023, of a complainant alleging a needle was embedded in the patient’s deep subcutaneous tissue. Your firm did not process the allegation as required in the Complaint Handling Procedure, GOP-0006, Rev 14 (OCT-11-2023), which states “This procedure applies to all external and internal complaints handling in SOLM Globally.”

b. Your firm did not implement the requirements of the Complaint Handling Procedure, GOP-0006, Rev 14 (OCT-11-2023), Section 7.2.2, to evaluate confirmed complaints for Medical Device Reporting to the FDA. For example,
    i. Complaint CF-244 (investigation completed October 12, 2023) involving reports of cracked SOL-M 10ml Luer Lock Syringe w/o Needle (Lot 04108072) was confirmed in the complaint investigation, but not evaluated for Medical Device Reporting to the FDA.
    ii. Complaint CF-284 (investigation completed November 09, 2023) involving reports of cracked SOL-M 20ml Eccentric Tip Syringe w/o Needle (bulk, sterile) (Lot 04212043) was confirmed in the complaint investigation, but not evaluated for Medical Device Reporting to the FDA.

The adequacy of your firm’s responses cannot be determined at this time. Your firm’s January 12, 2024, response indicates that your firm initiated a CAPA (CAPA-22) and a Complaint File (CF-380) in response to the observation, and the estimated completion date is February 15, 2023 [sic]. The response also states that your firm has corrected the reportability form by consolidating the reportability assessments of all major regions where your firm’s devices are marketed into a single form, GF-0080 (Event Reporting – Vigilance Decision Making Form, Rev 01), and has obsoleted the regional forms, GF-0081 and GF-0082. In addition, the response indicates your firm has filed the two (2) complaints CF-244 and CF-284 as Medical Device Reportable events with FDA, as of December 27, 2023, MDR numbers are 3014312726-2023-00010 and 3014312726-2023-00011, respectively. However, documentation or evidence of completed corrective actions was not provided. Your response included a blank copy of the updated GF-0080 form but failed to include completed updated GF-0080 forms documenting your firm’s reportability assessments. Supporting documentation, such as the completed CF-380, CAPA-22, and GF-0080, was not provided to show corrective actions have been completed. Also, your response indicates employee training is projected for completion by February 15, 2024, as part of your firm’s corrective actions. We cannot determine the adequacy of your firm’s response concerning the projected employee training because no training documents reflecting these updates to complaint handling have been provided.

3. Failure to maintain adequate records of the investigation by the formally designated unit identified in 21 CFR 820.198(a) when an investigation is made, as required by 21 CFR 820.198(e).

Records of complaint investigations do not include required information, including any unique device identifier (UDI) or universal product code (UPC). Specifically, your firm did not implement the requirements of the Complaint Handling Procedure, GOP-0006, Rev 14 (OCT-11-2023), Section 4.12 and the Corporate Vigilance Reporting Procedure, GOP-0007, Rev 8 (11-OCT-2023), Section 7.2.1, to include the UDI on applicable records that are printed from your firm’s current electronic Quality Management System (e-QMS), including but not limited to Customer Feedback Reports, Complaint Investigation Forms and Official Response Letters. The UDI is also not recorded on the Event Reporting – MDR record which is uploaded to the applicable complaint record in the e-QMS. For example,
    i. CF-256 (09/28/23 - 10/25/23), involving the MONOJECT Hypodermic Safety Needle 25G*1", does not include a recorded UDI on the Customer Feedback Report, Complaint Investigation Form, Official Response Letter, and the record of Event Reporting – MDR.
    ii. CF-295 (11/16/23 - 11/27/23), involving the SOL-CARE Safety Needle 25G*5/8", does not include a recorded UDI on the Official Response Letter and the record of Event Reporting – MDR.

The adequacy of your firm’s responses cannot be determined at this time. Your firm’s January 12, 2024, response indicates that your firm initiated a CAPA (CAPA-23) in response to the observation. In addition, your response indicates UDI information for all complaints will be updated where the UDI data is lacking and is estimated for completion by February 15, 2024. The response also states that the Event Reporting – Vigilance Decision Making Form, GF-0080, Rev 01 will require the UDI information for all product complaints logged into your firm’s e-QMS. Supporting documentation, such as CAPA-23, is not provided to demonstrate the corrective actions taken have been verified and/or validated as effective. Also, your response indicates your firm has updated the Complaint Handling Work Instruction, GWI-0013, Rev 02 (08-JAN-2024), as part of your firm’s corrective actions. Your response did not include employee training requirements concerning the updated work instruction.

Medical Device Reporting Violations

Our inspection also revealed that your firm’s devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 - Medical Device Reporting. Significant violations include, but are not limited to, the following:

1. Failure to develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17.

For example, during the inspection, your firm identified the document titled “Corporate Vigilance Reporting Procedure”, Doc No.: GOP-0007, Revision 08, dated 11-OCT- 2023 as its written MDR procedure. However, our review concluded that the procedure does not contain information that would indicate that it was an MDR procedure created in accordance with the requirements in 21 CFR 803.17.

We reviewed your firm’s response dated January 12, 2024, and conclude that it is not adequate. The response includes copies of the following procedural documents as your firm’s revised MDR procedure.

a. “Corporate Vigilance Reporting Procedure”, Doc No.: GOP-0007, Revision 10, dated 10-Jan-2024
b. “Complaint Handling Procedure”, Doc No.: GOP-0006, Revision 15, dated: 05-Jan-2024
c. “Event Reporting - Vigilance Decision Making Form”, Doc. No.: GF-0080, Revision 01, dated 05-Jan-2024

After reviewing the revision, the following deficiencies were noted:   

i. The revision does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements, as required by 21 CFR 803.17(a)(1). For example, the revision omits the definition of the term “reasonably suggests” found in 21 CFR 803.20(c)(1). The exclusion of the definition for the term from the revision may lead your firm to make an incorrect reportability decision when evaluating a complaint that may meet the criteria for reporting under 21 CFR 803.50(a).
    ii. The revision does not establish internal systems that provide for timely transmission of complete medical device reports, as required by 21 CFR 803.17(a)(3). Specifically, the revision does not include:

1. Instructions for how to obtain and complete the FDA 3500A form.
2. How your firm will ensure that all information reasonably known to you is submitted for each event. Specifically, which sections of the Form 3500A will need to be completed to include all information found in your firm’s possession and any information that becomes available as a result of a reasonable follow-up within your firm.

Your firm’s response dated January 29, 2024, did not address the noted procedural deficiencies.

2. Failure to submit a report to FDA no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that your firm markets has malfunctioned and this device or a similar device that it markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur, as required by 21 CFR 803.50(a)(2). For example,

a. The information included for Complaint CF-37 and MedWatch report MW5118327 reasonably suggests that your firm’s needle malfunctioned (specifically, needle breakage) during use. A broken needle left in the patient would likely cause or contribute to a death or serious injury. There is no information included for the complaints that reasonably suggests that the needle left in the patient would not be likely to cause or contribute to a death or serious injury. Therefore, each event represents a reportable malfunction, as defined in 21 CFR 803.3. Your firm became aware of the referenced events on March 23, 2023, and June 16, 2023. However, the corresponding MDRs 3014312726-2023-00004 and 3014312726-2023-00005 were received by the FDA on June 6, 2023, and December 26, 2023, respectively, which exceeds the required 30-calendar day timeframe.

b. The information included for Complaint COMP-2021-0097 reasonably suggests your firm’s safety blood collection needle malfunctioned (specifically, luer connectivity failure), resulting in the splattering of HIV-positive patient blood. Although there was no injury reported in this incident, there is no information included for the complaint that reasonably suggests that the malfunction the device would not be likely to cause or contribute to a death or serious injury, if it were to recur. Therefore, the malfunction referenced for the complaint represents a malfunction that would be likely to cause or contribute to a death or serious injury if it were to recur. Your firm became aware of the event on April 29, 2021, and the corresponding MDR 3014312726-2024-00001 was received by the FDA on January 2, 2024, which exceeds the required 30- calendar day timeframe.

The adequacy of your firm’s response dated January 12, 2024, cannot be determined at this time. In the response, your firm mentions its root-cause investigation and plans to conduct a retrospective review of complaints received between January 2021 and December 2023. Your firm aims to submit any newly identified reportable events by February 15, 2024. As the planned corrective actions are still ongoing, we cannot determine the adequacy of the response.

Your firm’s response dated January 29, 2024, did not address the noted deficiencies.

Your firm should take prompt action to address any violations identified in this letter. Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.

Other federal agencies may take your compliance with the Act and its implementing regulations into account when considering the award of federal contracts. Additionally, should FDA determine that you have Quality System regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been addressed. Should FDA determine that your devices or facilities do not meet the requirements of the Act, requests for Certificates to Foreign Governments (CFG) may not be granted.

Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address any violations included in this Warning Letter. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration as part of your response.

Your firm’s response should be sent to: Melissa Michurski, Director of Compliance Branch, at oradevices2firmresponse@fda.hhs.gov. Refer to CMS # 677524 when replying. If you have any questions about the contents of this letter, please contact Salvatore Randazzo, Compliance Officer, at 407-475-4712 or salvatore.randazzo@fda.hhs.gov.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.

Sincerely,
/S/

Blake Bevill
Program Division Director
Office of Medical Device and Radiological Health
Division 2/Central

/S/

Kellie B. Kelm, Ph.D.
Acting Office Director
OHT3: Office of Gastrorenal, ObGyn,
General Hospital and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health