FDA WARNING_LETTER - Quality Dairy Company - January 17, 2020

The FDA inspected Quality Dairy Company's ready-to-eat food facility from January 8-17, 2020, identifying serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117). This rendered their products adulterated. Key violations included sanitation control procedures failing to ensure food-contact surface cleanliness and prevent cross-contamination (21 CFR 117.135(c)(3)), specifically regarding improper sanitizer use and incomplete written SSOPs. Additionally, sanitation monitoring records were not reviewed within seven working days (21 CFR 117.165(a)(4)), and the firm failed to implement environmental monitoring verification procedures as required (21 CFR 117.165(b)), with insufficient sampling and inadequate corrective action plans. Further, the facility failed to exclude pests, including cockroaches, rodents, and flying insects (21 CFR 117.35(c)), and did not adequately monitor conditions to protect finished food from contamination (21 CFR 117.80(c)(6)), evidenced by overspray onto cleaned equipment and improper cleaning tool usage. The FDA noted a positive Listeria seeligeri swab on a food contact surface and highlighted historical Listeria monocytogenes findings, including WGS evidence of a resident pathogen from 2016-2019, emphasizing the need for robust environmental monitoring. The firm's corrective action response lacked sufficient documentation, requiring verification. Prompt correction within 15 working days is mandated to avoid legal action and potential reinspection fees.