FDA 483 - Pharmacy Resources Incorporated - January 29, 2019

An FDA inspection of Pharmacy Resources Incorporated, a producer of sterile and non-sterile drug products, was conducted from January 9 to January 29, 2019. The inspection revealed several significant deficiencies, many of which were repeat observations, indicating non-adherence to Good Manufacturing Practices.

Key violations included: inadequate cleaning and disinfection systems for aseptic processing areas, with unvalidated disinfectants, non-sterile cleaning materials, and unapproved items in cleanrooms; a lack of validated sterilization processes, specifically in situ air pattern analyses; and insufficient protective apparel for personnel, leading to contamination risks. Additionally, the firm was cited for exposing sterile vials to less controlled environments before aseptic processing, lacking a written stability testing program for finished drug products, and failing to conduct adequate method suitability testing for in-house sterility tests. The environmental monitoring program for aseptic areas was also found to be deficient, with infrequent monitoring and a lack of investigation into positive results.

These observations necessitate that Pharmacy Resources Incorporated implement comprehensive corrective and preventive actions to ensure the quality, safety, and purity of its drug products.