FDA 483 - Isomeric Pharmacy Solutions, LLC - March 24, 2017

This FDA 483 document outlines significant compliance deficiencies observed at Isomeric Pharmacy Solutions, LLC, an outsourcing facility in Salt Lake City, UT, during an inspection from February 22 to March 24, 2017. The inspection identified fourteen observations, primarily reflecting a lack of adherence to Current Good Manufacturing Practices (CGMP). Key issues included a systemic failure to conduct thorough investigations for environmental monitoring excursions, out-of-specification (OOS) product results, visual inspection rejects, and media fill failures. The firm also failed to investigate 33 customer complaints related to product quality and patient safety, yet continued to release affected batches. Furthermore, product Beyond Use Dates (BUDs) lacked adequate support from stability studies, and critical equipment was found to be un-calibrated or un-qualified. Deficiencies were noted in aseptic processing validation, cleanroom cleaning practices, environmental controls (including inadequate smoke studies and improper gowning), and essential finished product testing for particulate matter. The Quality Control Unit also exhibited a lack of authority in reviewing and approving critical records, and employees were not adequately trained for key operational tasks. Many of these issues were repeat observations from a previous inspection, underscoring persistent quality system failures. Isomeric Pharmacy Solutions, LLC, is required to implement comprehensive corrective and preventive actions to address these fundamental deficiencies and ensure product safety and quality.