FDA 483 - PharMEDium Services, LLC. - February 22, 2013

This FDA Form 483 details numerous deficiencies observed during an inspection of a facility processing sterile injectable drug products.

**Facility and Operations:** The production area's air supply lacks an appropriate filtration system. Issues include no documentation for airflow studies (smoke studies) in horizontal laminar flow hoods (HLAF) or the clean room, no dynamic smoke studies during processing, and no raw data for HEPA filter integrity testing. Equipment is not suitably located, with items blocking return airflow vents in the ISO 7 clean room. Buildings are not maintained, with holes in walls near HLAFs and residue on walls.

**Violations and Quality System Issues:** * **Sterility and Pyrogen Testing:** Finished sterile injectable drug products are not laboratory tested for sterility and pyrogen (endotoxin) conformance; endotoxin testing is not performed on all batches. * **Sterilization Validation:** Media fills for validation and employee qualification do not represent continuous processes, testing only one stage at a time instead of the entire process from start to finished packaging. * **Product Release Testing:** Finished product potency and sterility testing are not performed on each lot; testing is only random per product family. * **Microbiological Contamination Prevention:** No sterile filtration is performed during aseptic processing. * **Equipment Maintenance:** Rust-colored buildup was noted behind a HEPA filter screen in Hood #13. * **Laboratory Controls:** Microbiological growth media monitoring lacks positive/negative