FDA 483 - Scientific Protein Laboratories, LLC - February 09, 2018

An FDA inspection conducted at Safeway Store #2839 in Fort Collins, CO, between January 18 and February 9, 2018, identified significant deviations from Current Good Manufacturing Practices (CGMP) for Finished Pharmaceuticals (21 CFR 210 and 211). This follow-up inspection, stemming from a previous Warning Letter, focused on the retail pharmacy's relabeling of over-the-counter (OTC) drug products and its handling of prescription drug dispensing errors.

Key observations included a lack of adequate written procedures for managing complaints related to relabeled OTC drug products, a repeat finding. Furthermore, the firm failed to conduct a thorough investigation into a serious dispensing error where approximately 120 prescriptions for Morphine Sulfate ER 60 mg were incorrectly filled with 100 mg tablets. The investigation lacked root cause analysis and failed to assess broader implications. Lastly, the inspection revealed a critical deficiency in staff training: pharmacists and pharmacy technicians involved in OTC relabeling had not received necessary CGMP training. Additionally, the Pharmacy Manager and staff demonstrated a lack of awareness regarding their CGMP responsibilities for relabeling operations, encompassing complaint handling, investigations, and training requirements. The company must address these issues to comply with regulatory standards.