# FDA WARNING_LETTER - Sunrise Donuts, LLC - June 27, 2013

Source: https://www.keypedia.com/records/warning_letter/sunrise-donuts-llc/d9ef3192-707a-465b-b369-f2b2eeda9d46

> FDA WARNING_LETTER for Sunrise Donuts, LLC on June 27, 2013. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Sunrise Donuts, LLC
- Inspection Date: 2013-06-27
- Product Type: Food
- Office Name: Detroit District Office
- Summary: On August 9, 2013, the FDA issued a Warning Letter to Sunrise Donuts, LLC, following an inspection from June 13-27, 2013, which revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110). These violations render the manufactured foods adulterated under section 402(a)(4) of the FD&C Act, as they were prepared, packed, or held under insanitary conditions. No written response to the FDA-483, issued on June 27, 2013, was received.

Key violations include:
1.  **Equipment and Utensil Sanitation (21 CFR 110.80(b)(1)):** Scrapers and spatulas were stored in soiled water, and mixing bowls/paddles had dry product residue.
2.  **Equipment Protection from Contamination (21 CFR 110.80(b)(7)):** Plastic bins and mixing vat paddles were stored on a soiled floor.
3.  **Work-in-Process Protection (21 CFR 110.80(b)(5)):** Yeast bags were observed inside a mixing bowl with donut dough, in direct contact with dry ingredients.
4.  **Pest Exclusion (21 CFR 110.35(c)):** The shipping

## Related Officers

- [Mr.](https://www.keypedia.com/people/manilal-j-chandhari/5a5f6304-320a-4a55-b02d-29dd8435ed1c)
- [Director](https://www.keypedia.com/people/glenn-t-bass/6b38b304-c54b-41db-b7bb-e777e6dc4bce)

Company: https://www.keypedia.com/companies/sunrise-donuts-llc/d5838915-4790-44ed-aeeb-5aafbd03da1c

Office: https://www.keypedia.com/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03