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

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