FDA 483 - Pharmedium Services, LLC - February 27, 2013

This FDA Form 483 details multiple violations observed during an inspection of a drug product manufacturing facility.

**Facility and Operations:** The facility manufactures and distributes sterile injectable drug products, including Oxytocin, Heparin, Cefazolin, Norepinephrine Bitartrate, Magnesium Sulfate, and Calcium Gluconate. Operations involve mixing and pooling sterile injectable drug products within ISO 5 laminar flow hoods.

**Violations and Observations:**

1. **Equipment Cleaning and Maintenance:** Laminar flow hoods (models 1, 2, 4, and 5) were observed with white and yellow residue (rough or crystalline) on HEPA filters and filter manifolds, up to eight inches square, in areas where sterile injectable drugs are pooled and mixed. Management stated no investigation or corrective action was documented for these residues. 2. **Personnel Clothing:** Employees in the clean room did not use non-shedding foot covers. White particles (2-3mm square) were observed on the clean room floor, potentially shedding from foot covers missing an elastic/rubber strip. 3. **Microbiological Contamination Prevention:** * Environmental sampling of personnel gowning was limited to fingertip contact plates from employees only; other gown areas were not sampled. * No monitoring of viable airborne particles for every lot or shift, only hood air and surface samples (SOP #CPS-707). * No monitoring of non-viable particles