Northern VA Compounders PLLC – FDA 483, Aug 10, 2016

On August 10, 2016, the FDA issued a Form 483 to Akina Pharmacy, located at 4080 Lafayette Center Drive, Suite 270, Chantilly, VA 20151, following an inspection conducted from July 25-27, 2016, and August 10, 2016. The firm, owned by Bassem Grigis, is a producer of sterile and non-sterile drug products.

The inspection revealed five observations:

1. **Inadequate Product Release Testing:** Identity and potency tests are not conducted for sterile drug products prior to release. Additionally, batches of sterile drug products formulated with Beyond Use Dates (BUD) are not consistently sterility tested. 2. **Unvalidated Cleaning Procedures:** Cleaning procedures for ISO 5 and ISO 7 areas have not been validated for effectiveness. Specifically, the firm uses a disinfectant/sporicide without demonstrating its effectiveness, and there is no established contact time for the solution. 3. **Quality Control Unit Deficiencies:** The quality control unit's responsibilities and procedures are not fully followed. For instance, containers of sodium chloride USP and ascorbic acid in the ante area lacked legible open or expiration dates, despite a monthly checklist requiring expiration dates for sterile chemicals. 4. **Failure to Follow Equipment Cleaning Procedures:** Written procedures for cleaning and maintenance of equipment are not followed. A