FDA WARNING_LETTER - Agila Corporation - September 12, 2023

The FDA issued a Warning Letter to Woody’s Pet Food Deli following an inspection from August 29 to September 12, 2023, which was a follow-up to a September 2, 2022, Untitled Letter. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) and the use of an unapproved food additive.

A sample of "Woody’s Pet Food Deli Raw Free Range Turkey with Supplements" (lot code 08/31/24) tested positive for *Salmonella Reading* and *Listeria monocytogenes*, rendering it adulterated. This product was voluntarily disposed of on September 19, 2023.

The facility failed to prevent adulteration and minimize undesirable microorganisms, as required by 21 CFR 507.25(c)(2). Their use of peroxyacetic acid (PAA) as a pathogen elimination method was ineffective, as evidenced by the positive sample taken after PAA application. This is a recurring issue, with previous FDA samples in 2019 and 2021 also testing positive for *Salmonella*. The FDA noted that *Salmonella* in pet food is a serious concern for both animal and human health, citing a 2019 human illness outbreak linked to the firm's product. The firm's response, citing USDA approval for human food and inability to eliminate pathogens completely