Ms. Ranki Liu
Product Technical Manager
Global Cosmetics Company Limited
No. 13 Gaobao Road, Changping Town
Dongguan Shi
Guangdong Sheng , 523581
ChinaFEI 3013749236Issued Apr 30, 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 3013749236.
Violations4
Issue DateApr 30, 2024
Product TypeDrugs
StatusOpen
Letter Details
Firm
Global Cosmetics Company Limited
Location
Ms. Ranki Liu
Product Technical Manager
Global Cosmetics Company Limited
No. 13 Gaobao Road, Changping Town
Dongguan Shi
Guangdong Sheng , 523581
China
FEI Number
3013749236
Country
China
Issue Date
April 30, 2024
Issuing Office
Center for Drug Evaluation and Research | CDER
Product Type
Drugs
Status
Open
Summary
Global Cosmetics Company Limited, a manufacturer of over-the-counter drug products including hand sanitizer, failed to conduct adequate identity testing of incoming components and active ingredients as required by Current Good Manufacturing Practice (CGMP) regulations, particularly failing to test ethanol for methanol contamination. The company's inability to demonstrate that raw materials conformed to appropriate specifications before use in drug manufacturing rendered their products adulterated under federal law. These significant violations of 21 CFR parts 210 and 211 were identified during FDA's review of records submitted in response to a September 2022 inspection request.
Global Cosmetics Company Limited FDA Warning Letter, April 30, 2024
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