FDA WARNING_LETTER - Distribuidora La Jugosita, Inc. - May 16, 2017

On April 26, 2017, the FDA inspected Distribuidora La Jugosita, Inc. in Cidra, Puerto Rico, and found serious violations of the Juice Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 120) and Current Good Manufacturing Practice (CGMP) regulation (21 CFR Part 110).

Key violations include: 1. **Failure to perform 5-log reduction:** The firm does not perform a 5-log reduction to address recontamination risk after repacking juice pulp and concentrates, as required by 21 CFR Part 120.24. The firm's June 2, 2017 response was inadequate as it did not address this. 2. **Inadequate sanitation monitoring:** The firm failed to adequately monitor sanitation conditions and practices per 21 CFR Part 120.6(b), specifically regarding pest exclusion, cross-contamination prevention, protection of food/packaging/contact surfaces, and cleanliness of food contact surfaces. The "Daily Sanitation Control Record" lacked exact times for monitoring. The firm's response regarding pest exclusion was inadequate, lacking evidence for proposed curtains, employee retraining, and corrective actions for rusted equipment. 3. **Improper raw material storage:** Raw materials were not stored to protect against contamination and minimize deterioration, violating 21 CFR Part 110.80(a