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

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