Northern VA Compounders PLLC, dba Akina Pharmacy — FDA Warning Letter Findings

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

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.

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

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…

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.

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…

Foreign matter in the production area.

Your firm used a (b)(4) for the purposes of product sterilization that was not appropriate for pharmaceutical use.

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…