# FDA WARNING_LETTER - Greenwood Ice Cream, LLC - June 25, 2021

Source: https://www.keypedia.com/records/warning_letter/greenwood-ice-cream-llc/eadfd45a-9afa-4fb6-b31a-6d3c427a8628

> FDA WARNING_LETTER for Greenwood Ice Cream, LLC on June 25, 2021. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Greenwood Ice Cream, LLC
- Inspection Date: 2021-06-25
- Product Type: Food
- Office Name: Office of Human and Animal Food Operations West Division 3
- Summary: The FDA issued a Warning Letter to a ready-to-eat (RTE) ice cream manufacturing facility in Chamblee, GA, following an inspection from June 22-25, 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).

Key violations include:
1.  **Adulterated Products:** Ice cream products were deemed adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions. Environmental samples tested positive for *Listeria monocytogenes* (L. mono), including a resident strain identified since 2016 through Whole Genome Sequencing (WGS), indicating inadequate sanitation controls.
2.  **Inadequate Preventive Controls:** The facility failed to identify and implement adequate preventive controls for environmental pathogens (L. mono), undeclared allergens (soy in "Jersey Cookie Monster Ice Cream" leading to a Class II recall), and physical hazards like metal contamination.
3.  **Insufficient Environmental Monitoring:** Written verification procedures for environmental monitoring were inadequate, with infrequent sampling and incomplete corrective action plans for positive results.
4.  **Hazard Analysis Deficiencies:** The hazard analysis did not properly evaluate pathogens in raw materials (e.g., nuts, strawberries added post-pasteurization) or establish a supply-chain program.

## Related Officers

- [Ingrid A. Zambrana](https://www.keypedia.com/people/ingrid-a-zambrana/122ef711-2d89-489b-a5e9-82893f58dd8f)
- [N’Jere P. English](https://www.keypedia.com/people/njere-p-english/985d9cd3-533b-41ef-aa62-92aa865b3c43)
- [Natalie Adan](https://www.keypedia.com/people/natalie-adan/b0f95d66-d552-4e5c-9559-dbb2b7c0b47e)

Company: https://www.keypedia.com/companies/greenwood-ice-cream-llc/cfb5bebc-7ebe-490e-bd59-bbd3943c9e3d

Office: https://www.keypedia.com/offices/office-of-human-and-animal-food-operations-west-division-3/e7f2e5ac-b72b-49d5-b816-8e5520334bee