FDA WARNING_LETTER - Fujian Guangyang Egg Industry Company Limited - September 23, 2019

The FDA conducted an inspection of Fujian Guangyang Egg Industry Company Limited, an LACF facility in China, on September 19, 20, and 23, 2019, revealing serious violations of the Emergency Permit Control (21 CFR 108) and Low Acid Canned Foods (21 CFR 113) regulations. Key deficiencies included failure to record processing and production information at the time of observation (21 CFR 113.100(a)), inadequate records for identifying initial product distribution and facilitating lot segregation (21 CFR 113.100(f)), and failure to review temperature-recording device records within one working day (21 CFR 113.100(b)). Additionally, the firm failed to record a critical factor, flow rate, as specified in their scheduled process (21 CFR 113.100(a)). The FDA found the company's written responses inadequate, citing a lack of supporting documentation and failure to fully address the violations. Consequently, the firm was placed on Import Alert #99-38, leading to detention without physical examination of its products. The FDA requires a written response within 15 working days detailing specific corrective actions with comprehensive documentation, including processing records. The FDA also strongly recommends engaging a qualified consultant for a comprehensive CGMP audit to ensure compliance and evaluate corrective actions. Failure to comply renders products adulterated and may incur re-inspection fees.