Mr. Rick Duncan
Plant Manager
Purina Animal Nutrition LLC
1402 E. Sarah DeWitt Dr.
Gonzales , TX 78629
United StatesFEI 1618285Issued Mar 8, 2022Division of Human and Animal Food Operations West III
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 1618285.
Violations5
Issue DateMar 8, 2022
Product TypeFood & Beverages
StatusClosed
Closeout LetterSep 20, 2022
Letter Details
Firm
Purina Animal Nutrition LLC
Location
Mr. Rick Duncan
Plant Manager
Purina Animal Nutrition LLC
1402 E. Sarah DeWitt Dr.
Gonzales , TX 78629
United States
FEI Number
1618285
Country
United States
Issue Date
March 08, 2022
Issuing Office
Division of Human and Animal Food Operations West III
Product Type
Food & Beverages
Status
Closed
Closeout Letter
September 20, 2022
Summary
Purina Animal Nutrition LLC's Gonzales, Texas facility manufactured animal feed products containing elevated urea levels that posed serious health risks and death to ruminant animals, leading to a Class I recall of four products in October 2021. FDA investigators found significant violations of Current Good Manufacturing Practice (CGMP), Hazard Analysis, and Risk-Based Preventive Controls requirements under 21 CFR Part 507, rendering the products adulterated. The inspection was conducted as a follow-up to the urea contamination recall, and the company had not responded to the FDA 483 observations issued at the close of inspection.
Purina Animal Nutrition LLC FDA Warning Letter, March 8, 2022
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