FDA WARNING_LETTER - United Taiwan Corp. - Chao Zhou Plant - August 06, 2010

The FDA inspected United Taiwan Corporation's Chao Zhou Plant, a low-acid canned food (LACF) facility, on August 5-6, 2010. The inspection revealed serious deviations from LACF regulations (21 CFR Parts 108 and 113), rendering their Sweet Red Beans product adulterated under Section 402(a)(4) of the Federal Food, Drug and Cosmetic Act.

Specifically, the firm failed to identify when processes were less than scheduled or when critical factors were out of control, as required by 21 CFR 113.89. For Sweet Red Beans, retort rotation was recorded as (b)(4) instead of the filed scheduled process's (b)(4), and a retort temperature for one batch was (b)(4) instead of the critical process temperature of (b)(4). The firm reviewed these records but did not identify the deviations or take corrective actions. Their August 16, 2010, response was deemed inadequate because it did not adhere to the filed scheduled process parameters.

The FDA also noted that the filed scheduled process parameters for Sweet Red Beans did not match those typically filed for (b)(4) processing. The firm must file a revised scheduled process electronically, including appropriate critical factors for end-over-end agitation processing in water.

The company must respond in writing within thirty working days, outlining specific corrective actions and providing supporting documentation.