FDA WARNING_LETTER - United King Foods Private Limited - October 25, 2024

The FDA issued a Warning Letter to Mr. Sheikh Muhammad Tehseen following a Foreign Regulatory Assessment (FRRA) of their LACF and snack food facility in Pakistan from October 21-25, 2024. Serious violations of 21 CFR 108 (Emergency Permit Control) and 21 CFR 113 (Thermally Processed Low-Acid Foods) were identified, rendering their Gulab Jamu product adulterated. Violations include the firm's failure to provide evidence that scheduled processes for LACF were established by a qualified person (21 CFR 113.83). The firm also failed to properly reprocess or set aside product when critical factors were out of control or processes were less than scheduled (21 CFR 113.89), with specific instances of Gulab Jamun Fo values being below minimum. Additionally, the firm did not accurately determine and record the initial temperature of container contents from the coldest can, nor did they identify process deviations (21 CFR 113.87(c)). Furthermore, plant personnel involved in thermal processing lacked supervision from a person who attended an FDA-approved school (21 CFR 113.10). Finally, production records, including temperature-recording device records, were not signed, initialed, or dated by a reviewer. The firm's submitted corrective actions were deemed inadequate due to a lack of supporting documentation. The firm must respond within fifteen working days with specific corrective steps, recurrence prevention measures, and documentation. They must also evaluate all U.S. market Gulab Jamun lots manufactured before October 25, 2024, for commercial sterility. Non-compliance could lead to refusal of admission and Detention Without Physical Examination (DWPE) for their imported products.