Marshalls Traditional Healthcare CC

Warning LetterOpen

Mr. Vick Maharaj Chief Executive Officer Marshalls Traditional Healthcare CC 560 Main Reef Road Germiston Gauteng 1400 South AfricaFEI 3014740544Issued Feb 10, 2025Center for Drug Evaluation and Research (CDER)

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Violations3

Issue DateFeb 10, 2025

Product TypeDrugs

StatusOpen

Letter Details

Firm: Marshalls Traditional Healthcare CC
Location: Mr. Vick Maharaj Chief Executive Officer Marshalls Traditional Healthcare CC 560 Main Reef Road Germiston Gauteng 1400 South Africa
FEI Number: 3014740544
Country: South Africa
Issue Date: February 10, 2025
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Drugs
Status: Open

Summary

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.

Marshalls Traditional Healthcare CC FDA Warning Letter, February 10, 2025