# FDA WARNING_LETTER - Ramar International Corporation - June 05, 2020

Source: https://www.keypedia.com/records/warning_letter/ramar-international-corporation/c2682a60-753a-41df-9289-18ea562ff1ae

> FDA WARNING_LETTER for Ramar International Corporation on June 05, 2020. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Ramar International Corporation
- Inspection Date: 2020-06-05
- Product Type: Food
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: The FDA inspected an RTE ice cream facility from May 20 to June 5, 2020, following a voluntary recall due to *Listeria monocytogenes* (L. mono) in product. The inspection revealed serious violations of the CGMP & PC rule (21 CFR Part 117), and environmental swabs confirmed L. mono presence, rendering the ice cream adulterated under 21 U.S.C. § 342(a)(4).

Key violations include:
- **Hazard Analysis Deficiencies:** Failure to identify environmental pathogens as a hazard requiring preventive controls for RTE ice cream exposed to the environment post-pasteurization (21 CFR § 117.130(a)(1), (c)(1)(ii)).
- **Sanitation Control Failures:** Recurring *Listeria spp.* findings in the facility, including L. mono genetically identical to a clinical isolate, indicating inadequate corrective actions. Specific issues included L. mono on a freezer door, broom bristles, and a cart used for transporting ingredients, demonstrating ineffective sanitation procedures (21 CFR § 117.80(c)(2)).
- **General GMP Violations:**
    - Contamination risk from dripping liquids onto exposed product containers and ingredients (21 CFR § 117.80(c)(2)).
    - Unsanitary grounds with standing water and gravel in material transport paths (2

## Related Documents

- [483 - 2020-06-05](https://www.keypedia.com/records/483/ramar-international-corporation/c7666294-d999-4f63-a550-16270c482537)

## Related Officers

- [Benson Yee](https://www.keypedia.com/people/benson-yee/8f7bce20-4a78-484a-87a3-849d195c58bc)
- [Darla R. Bracy](https://www.keypedia.com/people/darla-r-bracy/ff507c75-ede3-4915-9aea-d8971842d891)

Company: https://www.keypedia.com/companies/ramar-international-corporation/c4a1c621-4c98-4e25-a26b-bd146c2381bd

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b