FDA 483 - Premier Pharmacy Labs Inc - June 13, 2016

This FDA Form 483 details 20 observations from an inspection of an outsourcing facility.

**Facility and Operations:** The facility compounds various ophthalmic and injectable drug products.

**Violations and Observations:**

* **Aseptic Processing & Environmental Control:** * Deficient air supply in aseptic processing areas (HEPA filtered, positive pressure). * Lack of procedures for HEPA filter certification and airflow pattern studies (smoke studies) for ISO 5 areas. * Inadequate smoke studies showing non-unidirectional/turbulent air in ISO 5 laminar airflow working hood (LAFW), impacting multiple batches. * LAFW located in a cleanroom not suitable to prevent cross-contamination from personnel movement. * Environmental Monitoring (EMI) excursion investigations (fingertips) were incomplete, lacked timely CAPA, microorganism identification, and trend evaluation. * **Quality Control & Testing:** * Inadequate acceptance criteria for visual inspection of sterile products; 100% inspection not required, no defect criteria, and incomplete documentation of defects in batch records. * No retesting or re-examination of sterile plastic vials (droppers) after storage, lacking data to ensure sterility of re-sealed, opened vials. * **Equipment & Maintenance:** * Equipment not properly qualified during installation or maintained at appropriate intervals. * Failed media fill