AptaPharma Inc. – FDA 483, Aug 14, 2026

AptaPharma Inc. in Pennsauken, NJ, a contract manufacturer, was cited with two observations during an FDA inspection. The firm's stability program for drug products lacked specific test methods, leading to unsupported shelf life extensions for multiple liquid OTC products without adequate microbial testing. Additionally, laboratory controls were found deficient, as the firm used expired reference standards for analytical testing, compromising the validity of results.