FDA 483 - Pavilion Compounding Pharmacy - February 08, 2019

During an FDA inspection conducted from February 4-8, 2019, Pavilion Compounding Pharmacy, a producer of sterile and non-sterile drugs, received an FDA Form 483 detailing multiple observations of objectionable conditions. The inspection revealed significant deficiencies across several areas of drug manufacturing. Key issues included inadequate containment and cleaning practices during hazardous drug production, leading to potential cross-contamination, and environmental control concerns such as unsealed ceiling tiles in the cleanroom. Furthermore, the pharmacy failed to perform crucial quality control tests, specifically lacking potency testing for non-sterile drug formulations before release. Batch production and control records were found to be incomplete, missing vital information like equipment identity and laboratory results. Procedures to prevent insanitary conditions were also deficient, with examples including unrepresentative media fills, absence of dynamic smoke study documentation, lack of endotoxin testing for intrathecal products, and no evidence of filter integrity testing. These observations indicate deviations from regulatory expectations for drug manufacturing, requiring Pavilion Compounding Pharmacy to implement comprehensive corrective actions to ensure drug quality, safety, and compliance.