# FDA WARNING_LETTER - Ice Cream House LLC - March 26, 2024

Source: https://www.keypedia.com/records/warning_letter/ice-cream-house-llc/35f9a239-1a64-4c49-8264-e34b94986593

> FDA WARNING_LETTER for Ice Cream House LLC on March 26, 2024. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Ice Cream House LLC
- Inspection Date: 2024-03-26
- Product Type: Food
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: The FDA conducted a follow-up inspection of an RTE ice cream manufacturing facility from February 21 to March 26, 2024, prompted by a July 2023 multistate Listeria monocytogenes outbreak linked to the firm's products, which resulted in hospitalizations and a product recall. The inspection found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117). Environmental samples confirmed the presence of a resident L. monocytogenes strain in the RTE processing area, leading to a determination that the firm's products are adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions. Key violations include the failure to implement adequate preventive controls (21 CFR 117.135(a)(1)) for environmental pathogens, incomplete implementation of the allergen control program, a deficient supply-chain program (21 CFR 117.410(c)) lacking proper supplier verification, and poor CGMP maintenance (21 CFR 117.35(a)) evidenced by persistent leaks. The firm provided a response outlining corrective actions, which FDA will verify during a subsequent inspection. The company must respond within 15 working days detailing corrective steps to avoid potential legal action.

## Related Officers

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

Company: https://www.keypedia.com/companies/ice-cream-house-llc/87c5a1e7-dff1-4a72-aab2-8333d881d54d

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961