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

Source: https://www.keypedia.com/records/warning_letter/nrs-enterprises-inc-dba-sunflour-bakery/2765736e-f137-4b5c-9016-58ff56abeb37

> FDA WARNING_LETTER for NRS Enterprises, Inc. d/b/a Sunflour Bakery on March 06, 2024. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: NRS Enterprises, Inc. d/b/a Sunflour Bakery
- Inspection Date: 2024-03-06
- Product Type: Food
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: 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

## Related Officers

- [Darla R. Bracy](https://www.keypedia.com/people/darla-r-bracy/ff507c75-ede3-4915-9aea-d8971842d891)

Company: https://www.keypedia.com/companies/nrs-enterprises-inc-dba-sunflour-bakery/783c0b0b-c56c-4d4b-a787-21f930478a6e

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b
