FDA 483 - Northern VA Compounders PLLC - December 09, 2022

The FDA conducted an inspection of Northern VA Compounders PLLC, a producer of sterile drugs, from November 7 to December 9, 2022. The inspection revealed significant concerns regarding the firm's manufacturing processes and facility controls, indicating potential deviations from regulatory expectations for drug compounding.

Key violations included inadequate containment and cleaning practices for beta-lactam drugs, risking cross-contamination with other products. The company was found using non-pharmaceutical grade sterile components for injectables and non-pharmaceutical grade ingredients in non-sterile drug formulations, without proper quality testing. The sterile processing areas exhibited poor environmental control, with visibly dirty equipment, particle-generating surfaces, and chipping paint in critical zones. Furthermore, cleaning procedures for hazardous drug production were insufficient, leaving visible residues.

Observations also highlighted critical personnel and environmental control failures, such as improper aseptic techniques that obstructed sterile airflow and incorrect gowning practices. Deficiencies were noted in air pattern analyses (smoke studies), which failed to adequately simulate complex production processes or demonstrate effective HEPA filter coverage.

These issues fall under the regulatory framework of the Federal Food, Drug, and Cosmetic Act, which mandates adherence to current Good Manufacturing Practices to ensure drug quality and patient safety. Northern VA Compounders PLLC is required to provide a comprehensive response to the FDA, detailing the corrective and preventive actions implemented to address each observation and bring their operations into compliance.