Loading…
Marshalls Traditional Healthcare CC, a South African drug manufacturer, violated Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, rendering their OTC drug products adulterated. The company failed to conduct adequate finished product release testing for each batch, including testing for active ingredient identity and strength, as well as testing for objectionable microorganisms as required by 21 CFR 211.165(a) and (b). The violations were identified during an FDA inspection in September 2024, and while the company submitted a response indicating development of updated test methods and specifications, these deficiencies represented significant gaps in quality control and batch release procedures.