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 3014845221.
Violations10
Issue DateOct 22, 2024
Product TypeFood & Beverages
StatusOpen
Letter Details
Firm
Chongqing Tianrun Food Development Co., Ltd
Location
Yu Liao
General Manager
Chongqing Tianrun Food Development Co., Ltd
No. 99 Jiayuan Ave
Chongqing
Sichuan Sheng ,
China
531683392@qq.com
FEI Number
3014845221
Country
China
Issue Date
October 22, 2024
Issuing Office
Human Foods Program
Product Type
Food & Beverages
Status
Open
Summary
Chongqing Tianrun Food Development Co., Ltd, a manufacturer of low-acid canned foods intended for U.S. export, failed to comply with FDA regulations governing the processing and safety of thermally processed foods in hermetically sealed containers. During an April 2024 inspection, the FDA identified serious deviations from 21 CFR Parts 108 and 113, including failures to meet Emergency Permit Control registration and process filing requirements under 21 CFR 108.35. These compliance failures expose the company to potential emergency permit control enforcement actions under section 404 of the Federal Food, Drug, and Cosmetic Act.
Chongqing Tianrun Food Development Co., Ltd FDA Warning Letter, October 22, 2024
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