FDA 483 - Pharmedium Services, LLC - July 16, 2015

The FDA Form 483 details significant deficiencies at a facility producing sterile injectable drug products, including epidural and intrathecal injections.

Key violations include: * **Aseptic Processing Deficiencies:** Use of non-sterile cleaning agents (one ingredient not sterile) in ISO 7 room, lack of contact times in cleaning procedure CPS-301, and failure to control spore-forming organisms. Environmental monitoring records since 2015 show 48 action/alert levels (including 1 "too numerous to count" CFU) with various Bacillus species identified for personnel and ISO 5 monitoring. Non-sterile wipes stored in the ISO 7 area were observed hanging out of their tote, risking microbial contamination. * **Inadequate Investigations:** Failure to thoroughly investigate environmental monitoring excursions (action/alert levels) and continued product release without assessing the impact on finished products. * **Environmental Monitoring System Deficiencies:** Environmental procedure lacks daily employee monitoring (only gloves and gowns tested). * **Microbiological Contamination Prevention:** Media fills do not simulate actual production, quantities, or different drug product containers. Technician qualification media validation is incomplete. Personnel observed violating aseptic procedures (e.g., placing heads under laminar flow hood, touching non-sanitized items without re-gowning/sanitizing, leaning on hoods, contaminating ISO 5 area during setup). * **Product Release and Testing:** All products are released without laboratory analysis