FDA WARNING_LETTER - Hashimoto Shokuryo Kogyo Co., Ltd. - September 02, 2014

The FDA issued a Warning Letter to Hashimoto Shokuryo Kogyo Co. Ltd. following a September 2014 inspection of their low-acid canned food (LACF) facility in Japan. The inspection revealed serious deviations from Emergency Permit Control (21 CFR 108) and Thermally Processed Low-Acid Foods (21 CFR 113) regulations, with the firm's subsequent corrective action responses deemed inadequate. Key violations include the failure to register the establishment and file scheduled processes with the FDA, despite continued importation of LACF products after their registration was voided. The firm also failed to ensure product initial temperatures met scheduled process requirements, document deviations from critical factors like fill weight and syrup strength, and properly code hermetically sealed containers with required identifying information. Furthermore, the company did not perform adequate and frequent teardown examinations for seam integrity, nor did it enter processing information at the time of observation, instead pre-recording data. These deficiencies render the firm's LACF products adulterated under the Food, Drug and Cosmetic Act. The FDA requires a written response within 15 working days detailing specific corrective actions and supporting documentation. Failure to comply may result in refusal of admission for products into the U.S., detention without physical examination, and potential reinspection fees. The firm is responsible for ensuring full compliance with all applicable FDA regulations.