FDA WARNING_LETTER - TP. Food Canning Ltd., Part. - September 17, 2019

On January 22, 2020, the FDA issued a Warning Letter to Mr. Jittasirinuwat, referencing an inspection of their low-acid canned food (LACF) facility in Chiang Mai, Thailand, conducted on September 16-17, 2019. The inspection revealed serious deviations from the Emergency Permit Control regulation (21 CFR Part 108) and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR Part 113). An FDA-483, Inspectional Observations, was issued, but no response with corrective actions had been received.

The significant violations include the failure to file scheduled processes with the FDA for bamboo shoots in water packaged in cans, as required by 21 CFR 108.35(c)(2). Additionally, the firm did not provide evidence that scheduled processes for low-acid and acidified food products were established by a qualified person, as mandated by 21 CFR 113.83. Specifically, critical parameters like minimum time and temperature for processing bamboo shoot tips were not established, and validation records (e.g., temperature distribution or heat penetration data) were not provided despite a promise to consult a process authority.

The FDA requires a written response within fifteen working days, outlining specific corrective actions, including documentation and processing records for five product lots. Failure to respond or an inadequate response