# FDA WARNING_LETTER - Tropical Bakery Wholesale - September 26, 2019

Source: https://www.globalkeysolutions.net/records/warning_letter/tropical-bakery-wholesale/01ac319e-927c-4686-969a-1e7e6eb0f5aa

> FDA WARNING_LETTER for Tropical Bakery Wholesale on September 26, 2019. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Tropical Bakery Wholesale
- Inspection Date: 2019-09-26
- Product Type: Food
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: The FDA inspected a facility manufacturing ready-to-eat baked and frozen breads and pastries in Hialeah, Florida, from September 9-26, 2019. The inspection revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food regulation (21 CFR Part 117), leading to the determination that the bakery products are adulterated.

Key violations include:
1.  **Lack of Food Safety Plan:** The facility failed to prepare and implement a food safety plan, including hazard analysis, preventive controls, supply-chain program, recall plan, monitoring procedures, corrective action procedures, and verification procedures, as required by 21 CFR §117.126.
2.  **Inadequate Hazard Analysis:** No hazard analysis was conducted for products, specifically failing to identify and evaluate undeclared allergens, biological hazards (e.g., *Clostridium botulinum*, *Salmonella*), environmental pathogens (*Listeria monocytogenes*), and mycotoxins.
3.  **Pest Control Deficiencies:** Numerous live flies, a live bird, and live roaches were observed in processing and storage areas. Exterior doors lacked adequate screening, and clutter outside could harbor pests.
4.  **Insufficient Cleaning and Sanitation:** Unclean utensils and equipment with heavy food residue were observed, leading to potential allergen cross-contact and microbial contamination. No written sanitation procedures were

## Related Documents

- [WARNING_LETTER - 2010-06-03](https://www.globalkeysolutions.net/records/warning_letter/tropical-bakery-wholesale/42eb28ac-9dd4-4111-ac66-47a06f96350c)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/tropical-bakery-wholesale/0f19bd74-f71f-4ebb-81d4-a86083b27eb5

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-iv/a8c8fd15-4e7a-46cb-903a-9980f7ea89e6