FDA 483 - Fagron Compounding Services - June 28, 2024

The FDA Form 483 details seven observations from an inspection of a sterile drug product outsourcing facility.

**Observation 1** cites a failure to establish, write, and follow procedures to prevent microbiological contamination of sterile drug products. This includes releasing nine batches of sterile products since 2023 despite positive microbial growth detected during environmental and personnel monitoring in ISO 5 aseptic areas. Specific contaminants like *Staphylococcus capitis*, *Staphylococcus epidermidis*, and *Bacillus licheniformis* were found on operators' gloved hands, settle plates, or active air samples. The firm's investigation indicated minimal exposure for syringes and IV bags, but sterility assurance was lacking. Cleanroom qualification after reconstruction in early 2023 was inadequate, with only one filling room and associated areas qualified before production resumed, leaving other connected rooms unqualified until July 2023. Qualification of ISO 5 Laminar Airflow Hoods was also inadequate, with multiple HEPA filter leaks, air velocity deviations, and discoloration found in January 2023 and 2024 certifications. Disinfectant efficacy validation was insufficient, omitting IV bag and glove surfaces from studies, and lacking validation for another sanitizer.

**Observation 2** notes a failure to thoroughly review unexplained discrepancies and out-of-specification (OOS) results, including 22 deviations from OOS gloved hand and settle plate results since 2023.

**Observation 3