FDA WARNING_LETTER - Poinciana Milling Complex - August 06, 2014

The FDA conducted inspections at Poinciana Milling Complex, Inc. from June to August 2014, revealing serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110). The facility's food products were found to be adulterated under Section 402(a)(4) and 402(a)(3) of the Federal Food, Drug and Cosmetic Act due to insanitary conditions and confirmed presence of insects, including sawtoothed grain beetles (larvae, pupae, cast skin).

Specific violations included: 1. Observation of live and dead insects (sawtoothed grain beetles, Indian Meal Moths, flat grain beetles, red flour beetles, Australian cockroaches) in, on, and near food throughout the facility. 2. Failure to properly manage rubbish (21 CFR 110.37(f)): Approximately 600-700 metric tons of rice stored outdoors was exposed by torn tarps, showing moldy rice and surrounded by green standing water and numerous insects. An uncovered trash receptacle with a foul odor was near a building with a pest entry point. 3. Failure to have smoothly bonded or well-maintained seams on food contact surfaces (21 CFR 110.40(b)), leading to product buildup. 4. Failure to ensure plant equipment and utensils are adequately cleanable and maintained (21 CFR 1