FDA WARNING_LETTER - Evanger's Dog & Cat Food Company, Inc. - February 10, 2011
Discuss this record with AI
On May 5, 2011, the FDA issued a Warning Letter to Evanger’s Dog & Cat Food Company, Inc. following an inspection from December 2, 2010, to February 10, 2011, and sample analysis. The letter identified significant violations of the Federal Food, Drug, and Cosmetic Act.
The company's "(b)(4) Lamb and Rice Dog Food" was found to be adulterated under Section 402(b)(2) because lamb was not detected, and bovine material was substituted. It was also misbranded under Section 403(b) for being sold under the name of another food.
Additionally, "Evanger’s Grain-free Duck Pet Food" was adulterated under Section 402(b)(1) as duck, a valuable constituent, was omitted. It was also misbranded under Section 403(a)(1) because the labeling falsely claimed the presence of duck.
Furthermore, the firm failed to provide processing and production records for 2009 products upon written demand, violating 21 C.F.R. 108.35(h).
Evanger's was instructed to take prompt corrective action and respond within fifteen working days, detailing steps taken or planned to correct violations and prevent recurrence. Failure to comply could result in regulatory actions like seizure or injunction.
ID · c927093f-8d4a-415a-a9c1-9fc0a1c9af97
Full citation text and observation details available on the Dashboard.