PharMEDium Services, LLC. – FDA 483, Dec 15, 2017

The FDA Form 483 details numerous deficiencies at a drug manufacturing facility, particularly concerning its quality control unit and aseptic processing. The quality control unit lacks the authority to adequately review production records, investigate errors, and conduct sufficient reviews for the release of final drug products, including those found to be out of specification.

Several lots were released and distributed despite being out of specification for environmental monitoring (ISO 5 hood, glove fingertip) and confirmed sterility (Lot 172040012M, Lot 172040203M with five microbes), endotoxin (Lot 171609019M), and potency (Lot 171709005M, super-potent Fentanyl Citrate). The QC Supervisor admitted to releasing batches from the Memphis facility without adequately reviewing lab investigations from other locations.

Further issues include a lack of investigations regarding system suitability failures, unjustified use of analytical instruments, and insufficient data for OOS determinations. Procedures for preventing microbiological contamination lack adequate sterilization process validation. The firm continued processing and released products after confirmed media fill failures. Aseptic processing areas are deficient in air supply filtration, positive pressure, and cleaning/disinfection systems.

Drug product records are not reviewed and approved by QC before release. Unexplained discrepancies and batch failures are not thoroughly reviewed. Computer system inputs/outputs are not checked for accuracy. Complaint handling procedures are not followed. Drug products