# FDA WARNING_LETTER - The Lennox, International, Inc. - March 20, 2020

Source: https://www.keypedia.com/records/warning_letter/the-lennox-international-inc/11053c42-fd51-4609-ae61-17fdb28f571c

> FDA WARNING_LETTER for The Lennox, International, Inc. on March 20, 2020. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: The Lennox, International, Inc.
- Inspection Date: 2020-03-20
- Product Type: Food
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: On February 20, 21, 24, 26, and March 2, 5, 16, and 20, 2020, the FDA inspected a facility located at 930 New Durham Road, Edison, New Jersey, 08817-2241. This inspection was a compliance follow-up to a Class I recall of pig ear pet treats due to Salmonella contamination, which caused a nationwide outbreak resulting in 154 illnesses and 35 hospitalizations.

The inspection revealed significant violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (PCAF) regulation, 21 CFR Part 507. Violations included:
- Lack of a written food safety plan [21 CFR 507.31(a)].
- Failure to ensure hygienic practices for personnel in contact with animal food [21 CFR 507.14].
- Inadequate cleaning of animal food contact surfaces [21 CFR 507.19(b)].
- Improper handling of work-in-process and rework to prevent contamination [21 CFR 507.25(c)(3)].
- Use of cleaning and sanitizing agents without sufficient detail for assessment [21 CFR 507.19(c)].

The letter also noted concerns regarding

## Related Officers

- [Director of Investigations Branch](https://www.keypedia.com/people/lori-a-holmquist/edc51081-53e8-4116-b3c3-68e36d038de0)

Company: https://www.keypedia.com/companies/the-lennox-international-inc/e780f1e9-e1ec-401b-80f1-b2a474a166f4

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e