FDA 483 - Specialty Medicine Compounding Pharmacy, P.C. - November 05, 2013

The FDA Form 483 details numerous deficiencies at a facility producing sterile injectable drug products, including Dextrose 50% and Methylcobalamin UDP PF 25mg/mL.

Key violations include: * **Aseptic Processing:** Procedures to prevent microbiological contamination are not established or followed. Process simulations (media fills) are inadequate, not reflecting worst-case conditions. Manual aseptic operations, such as filling 25 open vials in an ISO 5 hood and multi-day bulk solution transfers, pose contamination risks. * **Environmental & Personnel Monitoring:** The program is deficient, lacking routine personnel monitoring (every shift/multiple locations), passive/active viable air monitoring during production, and adequate surface monitoring frequency. Non-viable particulate monitoring is not performed routinely. * **Facility Controls:** Air pattern analyses (smoke studies) for ISO 5 hoods are not performed under dynamic conditions, and no video is maintained. Air pattern analysis for the ISO 7 buffer room is absent. HEPA filter integrity testing for ISO 7 cleanroom filters (installed 11/01/2013) has not been performed. Pressure differentials between ISO 5 hoods and the ISO 7 cleanroom are not continuously monitored. * **Gowning & Materials:** Gowning components (hair covers, masks, Tyvek suit) are not sterile, leaving exposed skin. Storage conditions and clean hold times for sterilized containers, closures, and