Mr. Greg Lavender
General Manager
Catwalk Cosmetic Laboratories Pty Ltd.
105 Capricorn Drive, Capricorn Park
Muizenberg
Western Cape
7945
South AfricaFEI 3014345294Issued Nov 21, 2024Center for Drug Evaluation and Research (CDER)
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3014345294.
Violations7
Issue DateNov 21, 2024
Product TypeDrugs
StatusOpen
Letter Details
Firm
Catwalk Cosmetic Laboratories Pty Ltd.
Location
Mr. Greg Lavender
General Manager
Catwalk Cosmetic Laboratories Pty Ltd.
105 Capricorn Drive, Capricorn Park
Muizenberg
Western Cape
7945
South Africa
FEI Number
3014345294
Country
South Africa
Issue Date
November 21, 2024
Issuing Office
Center for Drug Evaluation and Research (CDER)
Product Type
Drugs
Status
Open
Summary
Catwalk Cosmetic Laboratories Pty Ltd., a South African OTC drug manufacturer, failed to comply with Current Good Manufacturing Practice (CGMP) regulations, rendering its drug products adulterated. The company did not adequately test incoming components to verify their identity, relying instead on visual inspection of supplier certificates of analysis and informal checks like rancidity assessment. This violation of 21 CFR 211.84(d)(1) represented a significant gap in quality control for finished pharmaceuticals that the FDA identified during its review of records submitted in March 2024.
Catwalk Cosmetic Laboratories Pty Ltd. FDA Warning Letter, November 21, 2024
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