# FDA WARNING_LETTER - Maribel's Sweets, Inc. - June 17, 2021

Source: https://www.keypedia.com/records/warning_letter/maribels-sweets-inc/c45c83e3-7460-4ad0-bc36-9ebd8915be65

> FDA WARNING_LETTER for Maribel's Sweets, Inc. on June 17, 2021. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Maribel's Sweets, Inc.
- Inspection Date: 2021-06-17
- Product Type: Food
- Office Name: Office of Human and Animal Food Operations East – Division 1
- Summary: The FDA inspected a Ready-to-Eat (RTE) chocolate product manufacturing facility at 38 Dobbin Street, Brooklyn, NY, from June 1-17, 2021. 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), rendering the RTE chocolate products adulterated under 21 U.S.C. § 342(a)(4).

Key violations include:
1.  **Lack of a Food Safety Plan:** The facility did not prepare or implement a comprehensive food safety plan, including written hazard analysis, preventive controls, supply-chain program, recall plan, monitoring procedures, corrective action procedures, and verification procedures (21 CFR § 117.126(a)(1)).
2.  **Inadequate Hazard Analysis:** Failure to identify and evaluate known or foreseeable hazards such as allergens (wheat, milk, tree nuts, soy), bacterial pathogens (Salmonella in tree nuts/chocolate), mycotoxins (aflatoxin in tree nuts), and environmental pathogens (Salmonella for RTE products exposed to environment) (21 CFR § 117.130(a)).
3.  **Insufficient Preventive Controls:** No implemented preventive controls for hazards, specifically inadequate controls for undeclared allergens (evidenced by a December 2020 recall due

## Related Officers

- [Program Director](https://www.keypedia.com/people/ronald-m-pace/a79d2af4-650e-4220-8de1-92bbd284457d)

Company: https://www.keypedia.com/companies/maribels-sweets-inc/63062e06-9d56-402b-a3a2-2a27ccdc6f22

Office: https://www.keypedia.com/offices/office-of-human-and-animal-food-operations-east-division-1/d0bca745-2ece-476c-b957-ff51f011aca1