FDA WARNING_LETTER - Good Morning Seoul Corp. - June 10, 2014

The FDA issued a Warning Letter to Good Morning Seoul Corp. in the Republic of Korea following an inspection on June 9-10, 2014, which revealed serious deviations from Emergency Permit Control (21 CFR 108) and Thermally Processed Low-Acid Foods (21 CFR 113) regulations. The firm, a manufacturer of low-acid canned food (LACF) products for export to the U.S., failed to respond to the FDA-483. Key violations include: failure to provide FDA with scheduled process information for new LACF products, with many processes returned and not reflecting actual operations or critical factors like RPMs (21 CFR 108.35(c)(2)); failure to process LACF products in conformity with the scheduled process (21 CFR 108.35(c)(3)(i)); failure to provide necessary process and procedure information, such as temperature distribution and heat penetration studies, to determine scheduled process adequacy (21 CFR 108.35(c)(3)(ii)); and failure to chlorinate container cooling water in cooling canals and recirculated water supplies (21 CFR 113.60(b)). These deficiencies render the firm's LACF products adulterated. Good Morning Seoul Corp. must respond within 15 working days with corrective actions and documentation. Failure to comply may result in refusal of admission for imported products, including Detention Without Physical Examination (DWPE) under Import Alert #99-38, and assessment of reinspection fees. The firm is responsible for ensuring compliance with all applicable regulations, including cGMP.