Mr. Paul Huang
General Manager/CEO
Foshan Biours Biosciences Co., Ltd.
13 East Xile Road, Tower B F1 Complex Bldg.
Rooms 201, 202, 203 (2nd Floor) & 302 (3rd Floor)
Foshan Shi
Guangdong Sheng , 528137
ChinaFEI 3011474550Issued Mar 10, 2021Center for Drug Evaluation and Research
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 3011474550.
Violations4
Issue DateMar 10, 2021
Product TypeDrugs
StatusOpen
Letter Details
Firm
Foshan Biours Biosciences Co., Ltd.
Location
Mr. Paul Huang
General Manager/CEO
Foshan Biours Biosciences Co., Ltd.
13 East Xile Road, Tower B F1 Complex Bldg.
Rooms 201, 202, 203 (2nd Floor) & 302 (3rd Floor)
Foshan Shi
Guangdong Sheng , 528137
China
FEI Number
3011474550
Country
China
Issue Date
March 10, 2021
Issuing Office
Center for Drug Evaluation and Research
Product Type
Drugs
Status
Open
Summary
Foshan Biours Biosciences Co., Ltd., a manufacturer of over-the-counter drug products, failed to conduct adequate finished drug product testing prior to release, violating current good manufacturing practice (CGMP) regulations under 21 CFR parts 210 and 211. Specifically, the company distributed an OTC patch product into the United States without performing appropriate laboratory testing to confirm the identity and strength of the active ingredient, in violation of 21 CFR 211.165(a). These manufacturing and quality control deficiencies resulted in adulterated drug products as defined under the Federal Food, Drug, and Cosmetic Act.
Foshan Biours Biosciences Co., Ltd. FDA Warning Letter, March 10, 2021
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