FDA 483 - Marshalls Traditional Healthcare CC - September 23, 2024

An FDA inspection conducted from September 19-23, 2024, at Marshalls Traditional Healthcare CC, an OTC drug manufacturer located in Germiston, South Africa, identified significant deviations from regulatory requirements. The inspection revealed eight key observations regarding the company’s manufacturing processes and quality controls. Main issues included a failure to establish adequate written procedures for production and process controls, notably incomplete process validation for a US market product. The firm also lacked appropriate laboratory testing for active ingredient identity and strength in finished products and failed to conduct necessary microbial testing. Equipment design for water systems was found to be inadequate, leading to potential stagnation. Furthermore, cleaning and maintenance procedures for shared equipment were deficient, with validation studies lacking detailed descriptions, justification for product representation, and sampling locations. Component testing was incomplete, missing verification for certain raw material identities. The company also failed to establish time limits for production phases and demonstrated deficiencies in laboratory controls, including a lack of method suitability testing and validation for several analytical procedures. These observations highlight non-compliance with current Good Manufacturing Practice for drug products. Marshalls Traditional Healthcare CC is required to address these findings by developing and implementing comprehensive corrective and preventive actions to ensure product quality, safety, and regulatory adherence.