# FDA WARNING_LETTER - Sweet Ann Cake, Inc. - July 19, 2019

Source: https://www.keypedia.com/records/warning_letter/sweet-ann-cake-inc/b684d011-98d2-40de-baa3-b826df2af5f9

> FDA WARNING_LETTER for Sweet Ann Cake, Inc. on July 19, 2019. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Sweet Ann Cake, Inc.
- Inspection Date: 2019-07-19
- Product Type: Food
- Office Name: Office of Human and Animal Food Operations East Division IV
- Summary: The FDA inspected Carr #867 Km 7.8 Lote #3 Calle Bruno Cruz, Zona Industrial Toa Baja, Puerto Rico, from June 24 to July 19, 2019, finding serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117). This resulted in the facility's Ready-to-Eat (RTE) bakery products being deemed adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions.

Significant violations include:
1.  **Hazard Analysis (21 CFR §117.130(a)):** Failure to conduct a hazard analysis for products, specifically not identifying allergen cross-contact, pathogens (Clostridium botulinum, E. coli, Salmonella, Staphylococcus aureus), environmental pathogens (Listeria monocytogenes, Salmonella) for RTE foods exposed to the environment, and mycotoxins as known or reasonably foreseeable hazards.
2.  **Food Safety Plan (21 CFR §117.126(a)(1)):** Failure to prepare and implement a food safety plan.
3.  **Preventive Controls (21 CFR §117.135(a)):** Failure to identify and implement preventive controls (process, allergen, supply-chain) and establish written procedures

## Related Officers

- [Program Director](https://www.keypedia.com/people/ramon-a-hernandez/12807db4-f78b-4579-b66c-bae9096ec2d4)

Company: https://www.keypedia.com/companies/sweet-ann-cake-inc/21e7b938-3a48-4b24-a180-6642bd1d4379

Office: https://www.keypedia.com/offices/office-of-human-and-animal-food-operations-east-division-iv/29043e9a-ce51-494c-8f61-a5d82ef3fe1a