FDA 483 - MARSHALLS TRADITIONAL HEALTHCARE CC - September 23, 2024

Marshalls Traditional Healthcare CC, an OTC drug manufacturer in Germiston, South Africa, was inspected by the FDA and received a Form 483 with eight observations. The inspection revealed significant deficiencies in production and process controls, laboratory testing, equipment design and cleaning validation, and raw material testing. These issues indicate a lack of adequate controls to ensure the identity, strength, purity, and quality of drug products, posing potential risks to product quality and patient safety.