FDA WARNING_LETTER - Northern VA Compounders PLLC - December 09, 2022

The FDA issued a Warning Letter to Northern VA Compounders PLLC, dba Akina Pharmacy, following an inspection from November 7 to December 9, 2022. Investigators identified serious deficiencies in the firm"s drug product manufacturing, deeming products adulterated under Section 501(a)(2)(A) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions. Violations included using an inappropriate device for sterilization (labeled "research use only"), failing to confirm water quality for non-sterile drug production, and maintaining visibly dirty, particle-generating equipment and surfaces in aseptic processing areas. Foreign matter was also observed, and the firm failed to conduct adequate smoke studies to demonstrate unidirectional airflow, thereby risking sterile product contamination. While Akina Pharmacy initiated a voluntary recall of certain sterile products, the FDA found many of the firm"s corrective actions inadequate due to insufficient supporting documentation, such as missing equipment specifications, water quality certificates, and detailed smoke study reports. The FDA strongly recommends a comprehensive assessment of all operations, particularly aseptic processing, and advises engaging a third-party consultant with sterile drug processing expertise to address these critical issues.