Guangxi Jisheng Foods Inc – FDA Warning Letter, Jan 21, 2011

The FDA inspected Guangxi Jisheng Foods Inc.'s low-acid canned food facility in China from January 17-21, 2011, identifying serious deviations from 21 CFR Parts 108 and 113, which led to the issuance of an FDA-483. These failures render the firm's products adulterated under Section 402(a)(4) of the Federal Food, Drug and Cosmetic Act and could trigger emergency permit control provisions (21 CFR 108.35(k)). Key violations include the firm's failure to maintain heat distribution data demonstrating adequate venting, particularly concerning simultaneous retort venting contrary to process authority recommendations (21 CFR 113.40(a)(12)(iii)). Additionally, the firm failed to record required information on designated forms at the time of observation, with concerns about inconsistent clock calibration records and pre-signed blank QC records (21 CFR 113.100(a)). Lastly, the firm failed to mark hermetically sealed containers with a permanently visible identifying code, as evidenced by unlabeled and uncoded canned mushrooms in the warehouse (21 CFR 113.60(c)). The firm must respond within thirty working days, outlining specific corrective actions and providing supporting documentation. Failure to adequately respond may result in refusal of admission for imported products into the U.S., including Detention Without Physical Examination (DWPE).