§ 225.202 Formula, production, and distribution records

Records shall be maintained identifying the formulation, date of mixing, and if not for own use, date of shipment. The records shall be adequate to facilitate the recall of specific batches of medicated feed that have been distributed. Such records shall be retained on the premises for 1 year following the date of last distribution.

(Approved by the Office of Management and Budget under control number 0910-0152)

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What FDA inspectors cite under § 225.202

Form FDA 483 observations citing this section, fiscal years 2009–2025 (Veterinary Medicine).

• Elements of records 14
• Adequacy of Records 12
• Records kept one year 1

Warning letters citing § 225.202

2 FDA warning letters since 2017 cite this section :

• Gilman Cooperative Creamery Association 5 Oct 2018
• Cache Commodities Incorporated 23 Mar 2018

FDA guidance that cites § 225.202

• CVM GFI #272 Practices to Prevent Unsafe Contamination of Animal Feed from Drug Carryover 30 Jan 2023
• Product Recalls, Including Removals and Corrections: Guidance for Industry 2 Mar 2020
• CVM GFI #72 GMP'S For Medicated Feed Manufacturers Not Required to Register and be Licensed with FDA 1 May 1998

Amendment history

Federal Register documents that created or amended this section.

• 40 FR 14031 27 Mar 1975
• 51 FR 7390 3 Mar 1986