Northern VA Compounders PLLC, dba Akina Pharmacy
FDA issued a warning letter to Northern VA Compounders PLLC dba Akina Pharmacy (Sterling, VA) following a November–December 2022 inspection that found serious insanitary conditions in sterile drug compounding operations, including use of non-pharmaceutical-grade sterilization materials, inadequate water quality controls, dirty aseptic processing equipment, and insufficient smoke studies for airflow validation. These deficiencies caused compounded drug products to be adulterated under section 501(a)(2)(A) of the FDCA. The pharmacy had already initiated a voluntary recall of all sterile lots produced using materials labeled 'research use only,' but FDA found the firm's corrective action responses lacked adequate supporting documentation. FDA warned that failure to adequately address violations may result in seizure or injunction.
Required actions (3)
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.
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.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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