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 3012028711.
Violations8
Issue DateFeb 9, 2024
Product TypeFood & Beverages
StatusClosed
Closeout LetterMay 13, 2024
Letter Details
Firm
Hunan Gagazui Food Co., Ltd.
Location
Ms. Xia Wang
Owner
Hunan Gagazui Food Co., Ltd.
Sanfeng Industrial Park
Huarong Xian
Yueyang Shi
Hunan Sheng , 414200
China
FEI Number
3012028711
Country
China
Issue Date
February 09, 2024
Issuing Office
Center for Food Safety and Applied Nutrition (CFSAN)
Product Type
Food & Beverages
Status
Closed
Closeout Letter
May 13, 2024
Summary
Hunan Gagazui Food Co., Ltd. was cited for serious deviations from low acid canned food (LACF) regulations during an FDA inspection in November 2023. The facility failed to comply with Emergency Permit Control regulations (21 CFR Part 108) and Low Acid Canned Foods regulations (21 CFR Part 113), including mandatory requirements for registration and filing of process information under 21 CFR 108.25. The company did not respond to the FDA-483 inspectional observations issued at the conclusion of the inspection, and as a LACF manufacturer exporting to the United States, the firm now faces potential application of emergency permit control provisions that could restrict product importation.
Hunan Gagazui Food Co., Ltd. FDA Warning Letter, February 9, 2024