FDA WARNING_LETTER - LIANYUNGANG AIKANG FOOD CO., LTD - July 09, 2019

The FDA conducted an inspection of Lianyungang Aikang Food Co., Ltd. in China on July 8-9, 2019, revealing serious violations of the Emergency Permit Control (21 CFR Part 108) and Acidified Foods (21 CFR Part 114) regulations. The firm's July 30, 2019, response to the FDA-483 was deemed inadequate. Key violations include failure to implement appropriate quality control procedures, such as frequent testing and accurate record-keeping (21 CFR 114.80(a)), evidenced by pre-filled pH records and conflicting mixing records. The firm also failed to adequately test and examine containers to prevent leakage and contamination (21 CFR 114.80(a)(4)), with multiple dented cans observed. Furthermore, processing and production records were not maintained to show adherence to the scheduled process (21 CFR 114.100(b)), with missing records, lack of pH meter calibration records, and inaccurate time entries. These deficiencies render the firm's acidified food products adulterated under section 402(a)(4) of the Act. As a result, the firm was placed on Import Alert #99-38, meaning products may be refused admission into the U.S. The FDA recommends engaging a qualified consultant for a comprehensive CGMP audit. The firm must respond within 15 working days with specific corrective actions and supporting documentation, including processing records for five product lots, to address all identified violations and avoid re-inspection fees.