Arniruj Shinaprapha
Technical Compliance Officer
International Laboratories Corp. Ltd.
62 Moo 8, Bangna-Trad Road
Bang Phli
10540
Thailand
ra@ilc-cosmetic.comFEI 3006403166Issued Aug 8, 2023Center 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 3006403166.
Violations3
Issue DateAug 8, 2023
Product TypeDrugs
StatusOpen
Letter Details
Firm
International Laboratories Corp. Ltd.
Location
Arniruj Shinaprapha
Technical Compliance Officer
International Laboratories Corp. Ltd.
62 Moo 8, Bangna-Trad Road
Bang Phli
10540
Thailand
ra@ilc-cosmetic.com
FEI Number
3006403166
Country
Thailand
Issue Date
August 08, 2023
Issuing Office
Center for Drug Evaluation and Research | CDER
Product Type
Drugs
Status
Open
Summary
International Laboratories Corp. Ltd., a Thailand-based manufacturer of over-the-counter drug products, was found to manufacture adulterated drugs due to significant Current Good Manufacturing Practice (CGMP) violations. The company failed to conduct required identity testing on incoming drug components, particularly high-risk materials, and did not adequately verify that components met United States Pharmacopeia standards before use in manufacturing. These deficiencies in component testing and controls created unacceptable risks to product quality and safety.
International Laboratories Corp. Ltd. FDA Warning Letter, August 8, 2023
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