Mr. Alan Xu
General Manager
Imperial Palace Commodity -Dongguan- Co., Ltd.
No. 523 1st Liudong Road
Changlong Village
Huangjiang Town
Dongguan Shi
Guangdong Sheng , 523750FEI 3014838570Issued Jan 27, 2025Center 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 3014838570.
Violations5
Issue DateJan 27, 2025
Product TypeDrugs
StatusOpen
Letter Details
Firm
Imperial Palace Commodity -Dongguan- Co., Ltd.
Location
Mr. Alan Xu
General Manager
Imperial Palace Commodity -Dongguan- Co., Ltd.
No. 523 1st Liudong Road
Changlong Village
Huangjiang Town
Dongguan Shi
Guangdong Sheng , 523750
FEI Number
3014838570
Country
China
Issue Date
January 27, 2025
Issuing Office
Center for Drug Evaluation and Research (CDER)
Product Type
Drugs
Status
Open
Summary
Imperial Palace Commodity (Dongguan) Co., Ltd., an OTC drug manufacturer including alcohol wipes, failed to adequately test incoming components for identity, purity, strength, and quality, and did not validate or establish the reliability of its component suppliers' test analyses at appropriate intervals, violating 21 CFR 211.84(d)(1) and (d)(2). These Current Good Manufacturing Practice (CGMP) violations resulted in the company's drug products being deemed adulterated under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act. The FDA issued this warning letter on January 27, 2025, following the company's response to a March 4, 2024 records request and subsequent inquiries.
Imperial Palace Commodity -Dongguan- Co., Ltd. FDA Warning Letter, January 27, 2025
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