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WARNING LETTER 

WL # 671700 

4/12/2024 

Dear Mr. Girgis: 

From November 7, 2022, to December 9, 2022, U.S. Food and Drug Administration (FDA) investigators inspected your facility, Northern VA Compounders PLLC dba Akina Pharmacy, located at 23475 Rock Haven Way, Suite 105, Sterling, VA 20166. During the inspection, the investigators noted serious deficiencies in your practices for producing drug products, which put patients at risk. 

FDA issued a Form FDA 483, Inspectional Observations, to your firm on December 9, 2022. FDA acknowledges receipt of your facility’s response, dated January 20, 2023, as well as your subsequent correspondence. FDA also acknowledges that, on December 30, 2022, your facility initiated a voluntary recall of all lots of drug products intended or expected to be sterile, within expiry, that were produced using (b)(4) noted to be for “research use only”, due to a lack of sterility assurance. 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)].

B. Violations of the FDCA

Adulterated Drug Products

The FDA investigators noted that drug products 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 used a (b)(4) for the purposes of product sterilization that was not appropriate for pharmaceutical use.

2. Your firm failed to confirm that the quality of water was suitable for its intended use in the production of non-sterile drug products.

3. Your ISO (b)(4) classified aseptic processing areas had difficult to clean, particle-generating, and visibly dirty equipment and surfaces.

4. Foreign matter in the production area.

5. Your firm failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO (b)(4) area. Therefore, your products intended to be sterile are produced in an environment that may not provide adequate protection against the risk of contamination.

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 responses to the Form FDA 483. We acknowledge that, on December 30, 2022, your facility initiated a voluntary recall of all lots of drug products intended or expected to be sterile, within expiry, that were produced using (b)(4) noted to be labeled as for “research use only”, due to a lack of sterility assurance.

Regarding your responses related to the insanitary conditions, some of your corrective actions appear adequate; however, we cannot evaluate whether the following corrective actions described in your response appear to be adequate because you did not include sufficient information or supporting documentation:

1. Regarding your firm’s use of a (b)(4) for the purposes of product sterilization that was not appropriate for pharmaceutical use, we acknowledge your commitments and proposed corrective actions. However, you did not include adequate supporting documentation, such as specifications on the current (b)(4) being utilized and the certificate of analysis.

2. Regarding your firm’s failure to confirm that the quality of water was suitable for its intended use in the production of non-sterile drug products, we acknowledge your statement that, “Akina has sourced pharmaceutical grade (b)(4) water for non-sterile compounding from an NABP accredited drug distributor.” However, you did not include adequate supporting documentation, such as purchase records and thecertificate of analysis.

In addition, we note that your firm intends to wash glassware (before sterilization) with water from your (b)(4) water system. We acknowledge your statement that, “Akina has contracted with an EPA-certified contract laboratory to perform preventative-maintenance and testing on the (b)(4) system.” We reviewed the testing results provided in your response, which appear to only note the water passes the potability test required by the EPA. It is unclear how your firm determined that this water is suitable for cleaning glassware utilized in sterile production. For example, we are unsure whether your firm has endotoxin controls in place for your (b)(4) water system. Endotoxin control is critical for components used in sterile production, particularly those that are (b)(4) sterilized, which is not generally recognized as an effective method to reduce the level of endotoxins.

3. Regarding your firm’s ISO (b)(4) classified aseptic processing areas having difficult to clean, particle-generating, and visibly dirty equipment and surfaces, we acknowledge your commitments as well as your documentation demonstrating that staff have been retrained. Your response noted that non-viable and viable particle sampling was performed as part of your June 25, 2023, certification; however we have not received that supporting documentation for review. In addition, your response references Attachment 4D, but it does not appear to have been included for our review.

4. Regarding your firm’s failure to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO (b)(4) area, we acknowledge your commitments and we have reviewed your unidirectional flow device certification report, dated January 3, 2023. However, you did not include adequate supporting documentation, such as a detailed description of what was performed during the smoke studies and/or videos of the smoke studies. In addition, your response did not include your latest unidirectional certification report for your ISO (b)(4) BSC located within your “Sterile Hazardous Buffer Room.”

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.

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 processing expertise should assist you in conducting this comprehensive evaluation. 

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 any violations 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 address any violations. Failure to adequately address any 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 address any violations. Please include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. This letter notifies you of our concerns and provides you an opportunity to address them. If you believe your products are not in violation of the FDCA, include your reasoning and any supporting information for our consideration. If you cannot completely address this matter within fifteen (15) working days, state the reason for the delay and the time within which you will do so. 

Your written notification should refer to the Warning Letter # 671700. Please address your reply to: orapharm1_responses@fda.hhs.gov and Compliance Officer Juan Jimenez (Juan.Jimenez@fda.hhs.gov). 

Please identify your correspondence with Northern VA Compounders PLLC, dba Akina Pharmacy FEI # 3012590153; WL 671700 

Please provide acknowledgement of receipt of this communication.

Sincerely,
/S/

Lisa Harlan  
Program Division Director  
Office of Pharmaceutical Quality Operations Division I