FDA 483 - Logix Biosciences Inc. - August 11, 2023

Logix Biosciences Inc., an own-label distributor in Monterey, CA, received a Form 483 with two observations. The inspection revealed deficiencies in the firm's quality control unit responsibilities, including an inadequate quality agreement with its contract manufacturer, leading to a lack of reserve sample reviews and annual product reviews. Additionally, the firm's stability program for drug products was found to lack reliable test methods to identify degradation products and assess environmental effects.