Lystn LLC – FDA EIR, Dec 1, 2010

An FDA surveillance inspection of Lystn, LLC, a pet food distributor based in Fleetwood, PA, was conducted on December 1, 2010. This initial inspection was part of the agency's fiscal year 2011 work plan, specifically aligning with programs focused on ensuring compliance with pet food safety regulations, including those related to encephalopathy (ESE) and ruminant feed bans, as outlined in C.P. 7371.009 and 21 CFR 589.2000/2001.

Lystn, LLC operates as an own-label distributor of raw meat and raw milk pet food for dogs and cats. The company does not physically handle or store its products; instead, manufacturing is outsourced to third-party facilities. Despite not having on-site production or storage, Lystn, LLC maintains crucial control over the quality aspects of raw ingredients and product formulations for both its raw meat and raw milk lines. The inspection involved discussions with key management personnel, including Vice President of Operations Jacqueline C. Hill, President and CEO Keith A. Hill, and CFO Derrick J. Hill, who provided information on the firm's operations and recall procedures.

Significantly, the inspection concluded without the identification of any objectionable conditions or violations. No regulatory issues were observed, and no product samples were collected by the investigator. Consequently, since the firm was found to be operating in compliance with the reviewed regulatory frameworks, no specific corrective actions or mandated requirements were issued by the FDA at the conclusion of this inspection.