FDA WARNING_LETTER - Yuet Heung Yuen Sauce Food (ZhuHai) Co., Ltd - September 25, 2013

The FDA inspected Yuet Heung Yuen Sauce Food (Zhuhai) Ltd. in China from September 23-25, 2013, identifying serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123. An FDA-483 was issued. The firm's subsequent response, received October 1, 2013, described corrective measures but lacked supporting documentation, leaving FDA with continuing concerns. Specifically, the firm's HACCP plan for its oyster sauce failed to list undeclared allergens, such as soy, as a reasonably likely food safety hazard, violating 21 CFR 123.6(a) and (c)(1). Additionally, the HACCP plan lacked a critical control point to adequately control pathogen residue, particularly Clostridium botulinum germination, growth, and toxin formation, after the cooking process, which was deemed insufficient as the sole control strategy, violating 21 CFR 123.6(c)(2). Consequently, the firm's oyster sauce is considered adulterated. The FDA requires a written response within 15 working days detailing specific corrective steps, including a revised HACCP plan and five consecutive days of monitoring records. Failure to adequately respond may result in further action, such as refusal of admission for imported products, including Detention Without Physical Examination (DWPE), and assessment of re-inspection fees. The firm is responsible for ensuring full compliance with all applicable regulations.