PharMEDium Services LLC – FDA 483, Dec 13, 2017

This FDA Form 483 details multiple deficiencies observed during an inspection of an outsourcing facility producing sterile injectable/infusion drug products in syringes, bags, and cassettes.

**Key Violations and Observations:**

* **Failure to Reject Non-Conforming Products (Observation 1):** Drug products failing potency specifications were distributed. Examples include 10 mEq Potassium Chloride in 0.9% Sodium Chloride (lot 1706500800) and Potassium Phosphate in 0.9% Sodium Chloride (lot 170440840), both shipped despite failing initial and retest potency results. * **Inadequate Investigations (Observation 2):** The facility failed to thoroughly investigate unexplained discrepancies or batch failures, particularly regarding sterility failures. Investigations for multiple batches of Magnesium Sulfate, Potassium Chloride, and Diltiazem Hydrochloride, and a Potassium Phosphate lot, did not adequately assess other potentially impacted batches, personnel, or equipment through heightened sampling or increased environmental monitoring. * **Deficient Aseptic Processing Area Cleaning/Disinfection (Observation 3):** The system for cleaning and disinfecting aseptic processing areas was inadequate. "Too numerous to count" (TNTC) microbial results from technician glove samples (e.g., Bacillus Oceanisediminis, Bacillus Licheniformis) did not trigger additional sampling of products or equipment to determine contamination persistence. * **Incomplete Written Procedures for Microbiological Cont