Kilim Nong San – FDA Warning Letter, Jun 18, 2014

On June 17-18, 2014, the FDA inspected Kilim Nong San's acidified food facility in Korea, identifying a serious deviation from 21 CFR 108, Emergency Permit Control. The firm failed to manufacture acidified foods according to their scheduled process, specifically for (b)(4) products. The scheduled process included citric acid, a final (b)(4) pH, and post-filling hot water immersion for (b)(4) minutes. However, the inspection revealed citric acid was not added, pH was not measured, product was cooked at (b)(4) degrees, and no post-fill hot water immersion occurred.

Kilim Nong San's July 17, 2014, response acknowledged adding citric acid and measuring pH for (b)(4) products but lacked supporting processing records. Microbiological test results for E. coli were provided but do not substitute for a valid process established by a processing authority.

This violation renders their products adulterated under Section 402(a)(4) of the Act. The FDA may refuse admission of their products under Section 801 of the Act, including detention without physical examination (DWPE) via Import Alert #99-38. The firm must respond within 15 working days, outlining corrective actions with documentation. Failure to adequately respond may lead to further action and potential reinspection fees.