BBC Group Limited

Warning LetterOpen

Mr. Alan Wong General Manager BBC Group Limited Yangxia Development Zone Pumei Town Yunxiao County 363300 ChinaFEI 3010165327Issued Aug 4, 2021Center for Drug Evaluation and Research

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Violations6

Issue DateAug 4, 2021

Product TypeDrugs

StatusOpen

Letter Details

Firm: BBC Group Limited
Location: Mr. Alan Wong General Manager BBC Group Limited Yangxia Development Zone Pumei Town Yunxiao County 363300 China
FEI Number: 3010165327
Country: China
Issue Date: August 04, 2021
Issuing Office: Center for Drug Evaluation and Research
Product Type: Drugs
Status: Open

Summary

BBC Group Limited, a Chinese drug manufacturer, violated Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals and manufactured unapproved new drugs, specifically L.O.L. SURPRISE! branded scented hand sanitizers that were misbranded and introduced into interstate commerce without approval. During a March 2021 inspection, the FDA identified significant violations including failure to implement proper controls over computer systems to prevent unauthorized changes to master production records and other manufacturing controls. The company's April 2021 response to the FDA's inspection findings was deemed inadequate for failing to provide sufficient detail or evidence of corrective actions necessary to achieve CGMP compliance.

BBC Group Limited FDA Warning Letter, August 4, 2021