Mr. Nelson Wan
Official Correspondent
Guangzhou Four E’s Scientific Co., Ltd.
5th Floor, Building C
No. 2 Rui Tai Road
Huangpu Qu
Guangzhou Shi
Guangdong Sheng , 510700FEI 3009155756Issued Nov 13, 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 3009155756.
Violations1
Issue DateNov 13, 2024
Product TypeDrugs
StatusOpen
Letter Details
Firm
Guangzhou Four E’s Scientific Co., Ltd.
Location
Mr. Nelson Wan
Official Correspondent
Guangzhou Four E’s Scientific Co., Ltd.
5th Floor, Building C
No. 2 Rui Tai Road
Huangpu Qu
Guangzhou Shi
Guangdong Sheng , 510700
FEI Number
3009155756
Country
China
Issue Date
November 13, 2024
Issuing Office
Center for Drug Evaluation and Research (CDER)
Product Type
Drugs
Status
Open
Summary
Guangzhou Four E's Scientific Co., Ltd., an OTC drug manufacturer, failed to comply with Current Good Manufacturing Practice (CGMP) regulations, resulting in adulterated drug products. The company's quality control unit did not adequately ensure that manufactured drugs met established specifications for identity, strength, quality, and purity, and failed to provide sufficient oversight of its contract manufacturing organization to verify CGMP compliance. These deficiencies were identified through FDA's review of records submitted in response to a March 2024 inspection request.
Guangzhou Four E’s Scientific Co., Ltd. FDA Warning Letter, November 13, 2024
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