§ 225.10 Personnel

(a) Qualified personnel and adequate personnel training and supervision are essential for the proper formulation, manufacture, and control of medicated feeds. Training and experience leads to proper use of equipment, maintenance of accurate records, and detection and prevention of possible deviations from current good manufacturing practices.

(b)

(1) All employees involved in the manufacture of medicated feeds shall have an understanding of the manufacturing or control operation(s) which they perform, including the location and proper use of equipment.

(2) The manufacturer shall provide an on-going program of evaluation and supervision of employees in the manufacture of medicated feeds.

Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.

What FDA inspectors cite under § 225.10

Form FDA 483 observations citing this section, fiscal years 2009–2019 (Veterinary Medicine).

• Employees lack understanding 13
• Evaluation and supervision of employees 10
• Training 2

Warning letters citing § 225.10

4 FDA warning letters since 2017 cite this section :

• Ridley USA Inc. 3 Apr 2026
• Suther Feeds, Inc. 21 Aug 2023
• Nutra Blend, LLC subsidiary of Land O’Lakes 22 May 2023
• Land View, Inc. 7 Nov 2022

FDA guidance that cites § 225.10

• CVM GFI #272 Practices to Prevent Unsafe Contamination of Animal Feed from Drug Carryover 30 Jan 2023
• Draft Guidance for Industry: Questions and Answers on the Accredited Third-Party Certification Program draft 28 Apr 2022
• 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.

• 41 FR 52618 30 Nov 1976
• 42 FR 12426 4 Mar 1977