FDA 483 - Premier Pharmacy Labs Inc - June 12, 2019

From April 29, 2019, to June 12, 2019, an FDA inspection of Premier Pharmacy Labs Inc., an outsourcing facility located at 8265 Commercial Way, Weeki Wachee, FL, revealed multiple deficiencies. Vern A. Allen, CEO, was issued the report.

Key observations include:

* **Inadequate Investigations:** Failure to thoroughly investigate unexplained discrepancies, such as particles, fibers, and other defects in visually inspected sterile drug products. For example, Orphenadrine Citrate 30mg/ml lot ORP031119KMSECA had units rejected for fibers and foreign objects, but was still distributed. * **Aseptic Processing Deficiencies:** * Visibly stained HEPA filters in ISO 5 hoods. * Open air vents between cleanrooms and unclassified areas. * Deficient smoke studies with poor visualization of airflow patterns, a repeat observation from 2016. * Cleanroom certifications performed "at rest" instead of under dynamic conditions. * **Microbiological Contamination Prevention:** * Lack of controls for vials transferred from ISO 5 to ISO 7 cleanrooms with unseated stoppers, and use of non-sterile tools for crimping. * Media fill batch records lacking documentation of all interventions. * **Quality Control Unit