FDA 483 - Germaine Laboratories, Inc - September 27, 2023

Germaine Laboratories, Inc., a medical device manufacturer in San Antonio, TX, received five observations during an FDA inspection. The firm was cited for deficiencies in process validation approval, lack of established statistical techniques for process control, and inadequate implementation of corrective and preventive action procedures. Additionally, device history records lacked required acceptance documentation, and internal quality audit procedures were not adequately established or followed.