# FDA WARNING_LETTER - OFP Ingredients LLC - July 23, 2021

Source: https://www.keypedia.com/records/warning_letter/ofp-ingredients-llc/ffc10c95-02b3-4f39-b799-630b7d701adc

> FDA WARNING_LETTER for OFP Ingredients LLC on July 23, 2021. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: OFP Ingredients LLC
- Inspection Date: 2021-07-23
- Product Type: Food
- Office Name: Division of Human and Animal Food Operations - West I
- Summary: The FDA issued a Warning Letter to a dry milk powder processing facility following an inspection from May to July 2021, which revealed serious violations of the CGMP & PC rule (21 CFR Part 117). Environmental samples confirmed the presence of *Salmonella Cubana*, a human pathogen, indicating adulterated ready-to-eat (RTE) dry milk powder.

Key violations include:
1. **Inadequate Preventive Controls:** The facility failed to implement effective sanitation preventive controls for environmental pathogens like *Salmonella*, despite identifying them as a hazard. Whole genome sequencing showed the same *Salmonella* strain present since 2009, indicating a resident pathogen. Corrective actions for previous *Salmonella* findings were insufficient.
2. **Deficient Supply-Chain Program:** The facility did not adequately verify suppliers for hazards like *Salmonella* in lecithin. An audit certificate reviewed for a supplier covered the wrong location, and the correct certificate was outdated. Required testing for new suppliers was not conducted.
3. **Poor Manufacturing Conditions:** Leaking production equipment was observed, leading to water and liquid accumulation, and potential microbial growth. Forklifts used in non-production areas were found to spread *Salmonella* to production areas.
4. **Inadequate Hygienic Practices:** Employees handling equipment and product after cleaning were not wearing fresh uniforms.

The FDA requires a written response within 15 working days detailing corrective actions, recurrence prevention,

## Related Documents

- [483 - 2023-04-03](https://www.keypedia.com/records/483/ofp-ingredients-llc/9a7e729a-9426-465e-8c1e-d67d9f60ea16)

## Related Officers

- [Acting Assistant Commissioner](https://www.keypedia.com/people/michael-dutcher/5e9981f8-673f-4a2c-a0b5-dd5e8e8de1f4)

Company: https://www.keypedia.com/companies/ofp-ingredients-llc/f04b6854-d9e0-4ad7-977b-ee6f0f367252

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-i/1c3129a0-b8fd-4558-9283-44531498dbdd