FDA WARNING_LETTER - Native American Enterprises, LLC - July 19, 2013

The FDA inspected Native American Enterprises, LLC, a food processing facility, from June 24-July 19, 2013, and found serious violations of Current Good Manufacturing Procedures (CGMP) for Human Food (21 CFR Part 110). These violations render the food products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under insanitary conditions.

Specific violations include: 1. Failure to handle equipment, containers, and utensils to protect against contamination (21 CFR 110.80(b)(7)). An uncleaned control panel used as a storage shelf for a product scoop was contaminated by condensation. 2. Failure to maintain buildings, fixtures, or other physical facilities in a sanitary condition (21 CFR 110.35(a)). Walls, floors, and coving in the cook and pack-off rooms were in poor repair, with loose fiberglass panels, holes, loose caulking, and cracks preventing thorough cleaning.

Additionally, environmental samples collected during the inspection found *Listeria monocytogenes* and *Listeria welshimeri* in various processing area locations, indicating insanitary conditions.

The firm's July 29, 2013, response to the FDA-483 was deemed inadequate due to a lack of detail regarding proposed