FDA 483 - Wedgewood Connect, LLC - June 15, 2017

During an inspection conducted from June 7-15, 2017, the FDA issued a Form 483 to Leiter's Enterprises, Inc. dba Leiter's, an outsourcing facility in San Jose, CA, detailing significant observations related to their drug manufacturing processes. Key issues identified include inadequate personnel practices, where staff exhibited improper gowning techniques, compromising sterile gloves, and failing to maintain aseptic conditions. Procedures designed to prevent microbiological contamination during sterile drug production were not consistently followed, evidenced by poor cleaning methods for laminar flow hoods and incorrect placement of environmental monitoring equipment. Furthermore, both personnel and environmental monitoring methods were found to be insufficient, with operators performing samples incorrectly and failing to promptly label media plates. The facility's media fills and process simulations were deemed not representative of actual, challenging manufacturing conditions. Critically, the company failed to extend investigations of out-of-specification (OOS) results to other potentially affected products. Specifically, two lots of CTP drug product that did not meet specifications were released and distributed without notifying customers or initiating a recall. Leiter's is required to implement robust corrective and preventive actions to address these serious deviations and ensure adherence to Good Manufacturing Practices, thereby safeguarding product quality and patient safety.