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WARNING LETTER

WL # 558093

June 17, 2019

VIA UPS NEXT DAY AIR
Hank Incognito, Owner
Ideal Specialty Apothecary Inc.
dba Ideal Pharmacy
2333 Morris Avenue, Suite B101
Union, NJ 07083-5714

Dear Mr. Incognito:

From June 19, 2017, to August 31, 2017, U.S. Food and Drug Administration (FDA) investigators inspected your facility, Ideal Specialty Apothecary Inc., dba Ideal Pharmacy, located at 2333 Morris Avenue, Suite B101, Union, NJ 07083-5714. During the inspection, the investigators noted serious deficiencies in your practices for producing sterile drug products, which put patients at risk.

FDA issued a Form FDA 483 to your firm on August 31, 2017. FDA acknowledges receipt of your facility’s response, dated September 19, 2017. Based on this inspection, it appears that you produced drug products that violate the Federal Food, Drug, and Cosmetic Act (FDCA).

A. Compounded Drug Products Under the FDCA

Section 503A of the FDCA describes the conditions under which human drug products compounded by a licensed pharmacist in a State licensed pharmacy or a Federal facility, or a licensed physician, qualify for exemptions from three sections of the FDCA: compliance with current good manufacturing practice (CGMP) (section 501(a)(2)(B)); labeling with adequate directions for use (section 502(f)(1)); and FDA approval prior to marketing (section 505) [21 U.S.C. §§ 351(a)(2)(B); 352(f)(1), and 355(a)]. Receipt of valid prescriptions for individually identified patients is one of the conditions for the exemptions under section 503A.

B. Violations of the FDCA

Adulterated Drug Products

The FDA investigators noted that drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing your drug products to be adulterated under section 501(a)(2)(A) of the FDCA. For example, the investigators observed:

1. Your firm aseptically filled drug products intended to be sterile within a “(b)(4)” (b)(4) located in an unclassified environment. The (b)(4) was also operating at negative pressure to the surrounding unclassified area.

2. Your firm used non-sterile cleaning pads inside the ISO 5 aseptic processing area. Additionally, your firm stores pre-wetted sterile wipes in a re-sealable pouch within the ISO 5 area for an unspecified period of time, and there is no guarantee the wipes within the pouch remain sterile throughout their time of use.

3. Your firm failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO 5 area. Therefore, your products intended to be sterile are produced in an environment that may not provide adequate protection against the risk of contamination.

4. Your certification report of the ISO 5 classified (b)(4), dated (b)(4), did not include viable air monitoring in the ISO 5 aseptic processing area following HVAC construction in the production room.

5. Your media fills were not performed under the most challenging or stressful conditions. Therefore, there is a lack of assurance that your firm can aseptically produce drug products within your facility.

Under section 301(a) of the FDCA [21 U.S.C. § 331(a)], the introduction or delivery for introduction into interstate commerce of any drug that is adulterated is a prohibited act. Further, it is a prohibited act under section 301(k) of the FDCA [21 U.S.C. § 331(k)] to do any act with respect to a drug, if such act is done while the drug is held for sale after shipment in interstate commerce and results in the drug being adulterated.

C. Corrective Actions

We have reviewed your firm’s response to the Form FDA 483.

Regarding the insanitary condition observations in the Form FDA 483, we cannot fully evaluate the adequacy of the following corrective actions described in your response because you did not include sufficient information or supporting documentation.

1. Documentation was not provided to demonstrate that all wipes used in the ISO 5 area are sterile. Additionally, you stated that you have contacted the supplier of your sterile wipes stored in a re-sealable pouch for recommendations on duration of use in the ISO 5 environment and whether these wipes can be used as a disinfectant for compounding operations. However, you have not provided information or scientific justification for the storage of these wipes or indicated how they are being stored and used by your firm.

2. You did not provide a documented description of how dynamic conditions were simulated when performing the smoke studies.

3. Your response indicated that you would revise procedures for process simulation testing; however, you did not provide documentation which shows the specific changes made by your firm to your media fill procedures. Additionally, no documentation was provided to demonstrate that media fills that are representative of the most challenging conditions have been successfully performed.

You did not address certain observations related to insanitary conditions, for example:

1. Regarding your firm’s use of an (b)(4) to aseptically fill products intended to be sterile while operating under negative pressure to the surrounding unclassified environment, you did not propose any corrective actions.

2. Your firm did not address the lack of documented viable air monitoring in the ISO 5 aseptic processing area following HVAC construction in the production room where the ISO 5 (b)(4) is located.

In addition, as included in the Form FDA 483, viable air monitoring performed on April 28, 2017, recovered multiple microorganisms, including fungi, in the ISO 7 (b)(4) of the (b)(4). However, your written response does not include information regarding any actions taken by your firm to address this incident.

Please be aware that section 501(a)(2)(A) of the FDCA concerning insanitary conditions applies regardless of whether drug products you compound meet the conditions of section 503A [21 U.S.C. § 353a].

Should you compound and distribute drug products that do not meet the conditions of section 503A, the compounding and distribution of such drugs would be subject to the new drug approval requirement, the requirement to label drug products with adequate directions for use, and the drug CGMP regulations.

FDA strongly recommends that your management undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. In particular, this review should assess your aseptic processing operations. A third party consultant with relevant sterile drug manufacturing expertise should assist you in conducting this comprehensive evaluation.

In addition to the violations noted in the body of the letter, during the inspection in 2017, FDA investigators observed that your firm repackages Avastin (bevacizumab), a biological product subject to licensure under section 351 of the Public Health Service (PHS) Act. Please note that section 351(a)(1) of the PHS Act prohibits the introduction into interstate commerce of any biological product unless “a biologics license . . . is in effect for the biological product.” Although section 503A of the FDCA provides an exemption for certain compounded drugs from the requirement to obtain premarket approval under section 505 of the FDCA, it does not provide an exemption from the requirement to obtain premarket approval for biological products subject to licensure under section 351 of the PHS Act. Accordingly, biological products subject to licensure under section 351 of the PHS Act are not eligible for the exemptions for compounded drug products in section 503A of the FDCA. In other words, the FDCA does not provide a legal pathway for marketing biological products, including Avastin, that have been mixed, diluted, or repackaged outside the scope of an approved BLA.

In January 2018, following the inspection of your facility, FDA issued a final guidance for industry, “Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application,” that describes the conditions under which the Agency does not intend to take action for violations of section 351 of the PHS Act and section502(f)(1), section 582, and, where specified, section 501(a)(2)(B) of the FDCA when a state-licensed pharmacy, a federal facility, or an outsourcing facility dilutes, mixes, or repackages certain biological products outside the scope of an approved BLA. During our 2017 inspection, FDA investigators observed that your firm assigned the Avastin you repackaged a beyond use date (BUD) of 30 days. Please note that this 30-day BUD exceeds the BUD described in the final guidance cited above.

D. Conclusion

The violations cited in this letter are not intended to be an all-inclusive statement of violations at your facility. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.

Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Please include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you do not believe that the products discussed above are in violation of the FDCA, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen (15) working days, state the reason for the delay and the time within which you will complete the correction.

Send your electronic reply to [email protected]. Your written notification should refer to the Warning Letter CMS # 558093.

If you have questions regarding the contents of this letter, please contact Compliance Officer CDR Liatte Closs at [email protected].

Sincerely,
/S/

Craig Swanson
Acting Program Division Director/Deputy District Director
U.S. Food and Drug Administration
OPQO Division I/New Jersey District