FDA WARNING_LETTER - NRS Enterprises, Inc. d/b/a Sunflour Bakery - March 06, 2024

The FDA inspected a food manufacturing facility at 2950 Grace Lane, Costa Mesa, CA, from February 15 to March 6, 2024, finding serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food regulation (21 CFR Part 117). The firm manufactures ready-to-eat (RTE) bakery products.

Violations include the facility's RTE bakery products being adulterated due to insanitary conditions and misbranded due to labeling violations. The firm failed to prepare and implement a food safety plan, including a written hazard analysis, preventive controls (e.g., for allergens, environmental pathogens, mycotoxins), a supply-chain program, a recall plan, and monitoring, corrective action, and verification procedures. Specific issues included undeclared allergens (soy, walnuts, wheat, hazelnuts), allergen cross-contact (e.g., shared equipment, unwashed hands, uncleaned cooling racks), lack of environmental pathogen controls (e.g., re-used, unwashed gloves, bare-hand contact with RTE products, uncleaned cooling racks), and no mycotoxin control program for ingredients like wheat flour and tree nuts.

Additionally, the facility failed to adequately clean non-food-contact surfaces of equipment (mixers, ingredient bins, push carts, plastic curtains, bread slicer) and did not effectively exclude pests (flying insects, live and dead cockroaches