WARNING LETTER

September 22, 2023

Dear Ms. Sari:

During an inspection of your firm located in Solna, Sweden on June 5, 2023, through June 7, 2023, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Model 6210 radiographic table and Model S2 and S3 cystometric tables. 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 function of the body.

This inspection 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 Title 21, Code of Federal Regulations (CFR), Part 820. We received responses from you dated June 1, 2023, August 11, 2023, and September 1, 2023, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to your firm. We address these responses below, in relation to each of the noted violations. These violations include, but are not limited to, the following:

1. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specific requirements, as required by 21 CFR 820.50(a). Specifically, your firm’s current purchasing controls procedure, Supplier Evaluation, Rev 2, dated April 7, 2021, fails to define the frequency, type, and extent of control to exercise over suppliers, contractors, and consultants, based on the results of periodic evaluation. Additionally, your firm has not evaluated your contract repair/servicer, and the current contract Quality Assurance & Regulatory Affairs consultant. Further, your firm failed to maintain records covering evaluation of the current contract Quality Assurance & Regulatory Affairs consultant, who has been assisting your firm in overseeing and maintaining their Quality System procedures since the year 2020.

We reviewed your firm’s responses dated June 1, 2023, August 11, 2023, and September 1, 2023, and conclude that they are not adequate. Your firm’s responses state that you have revised the Supplier Evaluation SOP 1) to include the frequency and/or period for evaluation of suppliers, contractors, and consultants, 2) to include the type and extent of control to exercise over suppliers, contractors and consultants based on the results of the periodic evaluation, 3) to include evaluation of the contract repair/servicer for the Model 6210 radiographic table and Model S2 and S3 cystometric tables, and 4) to include requirements for assessment of contractors, consultants, and evaluation of the current contract QA/RA consultant. You state that appropriate staff has received training on the revised SOPs and forms. You have not completed the assessment and evaluation of the contract repair/servicer and your current contract Quality Assurance & Regulatory Affairs consultant. Additionally, you have not conducted a retrospective review of related documentation to ensure compliance with updated procedures. Although your firm’s responses state that you have updated the Supplier Evaluation procedures, the revised procedures were not included for our evaluation.

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, your firm’s procedure, Process description deviation management, Rev 1, dated November 25, 2020, fails to define requirements for review of complaints to determine if they should be evaluated for Medical Device Reporting. Additionally, your firm’s complaint records do not consistently include the dates and results of investigation (e.g., covering failures involving welding breakages and safety switches). Further, a review of a sampling of complaint records found five of five records do not list the Unique Device Identification (UDI) code for the subject devices.

We reviewed your firm’s responses dated June 1, 2023, August 11, 2023, and September 1, 2023, and conclude that they are not adequate. Your firm’s responses state that you have revised the complaint handling SOP to require dates and results of investigations and UDI code for subject devices. You also state that you have revised several forms including CAPA form and Non-Conformance Report form and trained the staff on the revised SOPs and forms. Also, you have not completed a review of complaints per the revised procedure to evaluate reportability for Medical Device Reporting and have not conducted a retrospective review of related documentation to ensure compliance with updated procedures. Although your responses state that you have updated the complaint handling procedures, the revised procedures were not included for our evaluation.

3. Failure to establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient, as required by 21 CFR 820.30(c). Specifically, your firm does not have procedures for defining a mechanism to resolve incomplete, ambiguous, or conflicting design requirements.

As of September 13, 2023, you have not provided a response to this observation.

4. Failure to establish and maintain procedures for validating the device design under defined operating conditions on initial production units, lots, or batches, or their equivalents, as required by 21 CFR 820.30(g). Specifically, your firm’s design validation procedure, Rev 1, dated January 22, 2021, does not fully define requirements to ensure devices are designed to meet user needs and intended uses. For example, the procedure fails to a) require the evaluation to be carried out on initial production units or their equivalents; b) require the evaluation to be carried out under actual or simulated use conditions.

As of September 13, 2023, you have not provided a response to this observation.

5. 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 does not have procedures for defining control for changes to existing device design requirements and design results, to include a) describing the changes and the reason for the changes; b) determining the need to verify and/or validate the changes; c) determining impact on the design risk analysis; d) determine any new regulatory requirements, such as premarket clearance or approval, as needed.

As of September 13, 2023, you have not provided a response to this observation.

6. Failure to establish and maintain procedures to control all documents, as required by 21 CFR 820.40. Specifically, your firm’s document controls procedure, Rev 1, dated December 15, 2020, does not require the approval of quality system documents to include the signature of the approving personnel and the date of that signature. Additionally, your firm has not fully implemented the current document controls procedure, which requires that you assign a unique document number to each quality system document, as multiple procedures do not feature a unique document number.

We reviewed your firm’s responses dated June 1, 2023, August 11, 2023, and September 1, 2023, and conclude that they are not adequate. Your firm’s responses state that you have revised the document controls SOP to implement Acrobat sign and included the requirement of signature of approving personnel and date on the approval of quality system documents, as well as to include a unique document number to each quality system document. However, you have not conducted a retrospective review of related documentation to ensure compliance with updated procedures. Although your response states that you have updated the document controls procedures, the revised procedures were not included for our evaluation.

Other federal agencies may take your compliance with the FD&C Act and its implementation 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.

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, including 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 action (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. Please provide a translation of documentation not in English to facilitate our review. We will notify you regarding the adequacy of your firm’s response(s) and the need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.

Your firm’s response should be sent via email to [email protected]. Refer to CMS case #667325 when replying. If you have any questions about the contents of this letter, please contact: Lu Jiang at +1(240)402-5779.

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/

Robert Ochs, Ph.D.
Director
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Cc:
Greg Swanson
US Agent
Emergo Global Representation LLC
2500 Bee Cave Road, Building 1, Suite 300
Austin, Texas 78746
[email protected]