FDA WARNING_LETTER - Lystn LLC dba Answers Pet Food - October 04, 2024

On June 18, 2025, the FDA issued a Warning Letter to Lystn LLC dba Answers Pet Food following an inspection from July 18 to October 4, 2024, at their Elizabethville, PA facility. The inspection revealed significant violations of FDA's Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals requirements (21 CFR Part 507), rendering products adulterated.

Key violations include: 1. **Inadequate Preventive Controls (21 CFR 507.34(a)(1))**: The company's food safety plan failed to control biological hazards (Salmonella, *Listeria monocytogenes*). FDA analysis of four retail pet food samples (Raw Beef Detailed Formula, Raw Beef Straight Formula, Straight Chicken Formula for Dogs) confirmed contamination with *Salmonella* and/or *L. monocytogenes*. 2. **Insufficient Sanitation Controls (21 CFR 507.34(a)(1), (c)(2))**: Environmental samples from July 23, 2024, showed *L. monocytogenes* on seven surfaces, including food-contact surfaces. Whole genome sequencing matched environmental isolates to *L. monocytogenes* found in a finished product. 3. **Inadequate Supplier Verification (21 CFR 507.115(a