U.L. Manufacturing Company Ltd. – FDA Warning Letter, Sep 19, 2017

On November 16, 2017, the FDA issued a Warning Letter to U.L. Manufacturing Company Ltd. following an inspection on September 19, 2017, of their acidified food (AF) facility in Jamaica. The inspection revealed serious deviations from the Emergency Permit Control regulation (21 CFR Part 108) and the Acidified Foods regulation (21 CFR Part 114).

Key violations include: 1. **Failure to File Scheduled Processes:** The firm failed to file scheduled processes with the FDA for Crushed Pepper Sauce, Pimento Sauce, Meat and Steak Sauce, and Fish and Meat Sauce, as required by 21 CFR 108.25(c)(2). Despite a response indicating intent to refile, no process filings have been received. 2. **Failure to Maintain Processing and Production Records:** The firm did not maintain records showing adherence to scheduled processes and critical factors, as required by 21 CFR 114.100(b). Specifically: * "Production Time/Temperature" was not recorded for "Hot Pepper Sauce" batches, despite a scheduled process requiring a minimum cook temperature of 92°C for 5 minutes. * No processing or production records were maintained for "Crushed Pepper Sauce" and "Hot Pepper Sauce" batches to ensure required times and temperatures were met. * The