FDA WARNING_LETTER - Great Oriental Food Products - January 21, 2011

The FDA inspected Great Oriental Food Products Co., Ltd.'s low-acid canned food facility in Thailand on January 20-21, 2011, identifying serious deviations from 21 CFR Parts 108 and 113. These violations render the firm's low-acid canned food products adulterated under Section 402(a)(4) of the Federal Food, Drug and Cosmetic Act. The inspection resulted in an FDA-483. Specifically, the firm failed to submit a complete description of modifications to a previously filed scheduled process for "Baby Corn (Whole Spear, Cut, Broken, Free Count) In Brine" within 30 days of first use, as required by 21 CFR 108.35(c)(2)(ii). Furthermore, the firm failed to process this product in conformity with the scheduled process filed with FDA, using a different process during the inspection, violating 21 CFR 108.35(c)(3)(i). Great Oriental Food Products must respond in writing within 30 working days, detailing corrective actions and providing supporting documentation, such as a heat distribution study. Failure to adequately respond may result in further FDA action, including refusal of admission for imported products under Section 801(a) of the Act and detention without physical examination (DWPE), potentially through Import Alert #99-04. The firm is responsible for ensuring full compliance with all applicable regulations.