21 CFR Part 225 · Current Good Manufacturing Practice for Medicated Feeds

§ 225.30 Equipment

Subpart B - Construction and Maintenance of Facilities and Equipment Official text on eCFR Amendment history

(a) Equipment which is designed to perform its intended function and is properly installed and used is essential to the manufacture of medicated feeds. Such equipment permits production of feeds of uniform quality, facilitates cleaning, and minimizes spillage of drug components and finished product.

(b)

(1) All equipment shall possess the capability to produce a medicated feed of intended potency, safety, and purity.

(2) All equipment shall be maintained in a reasonably clean and orderly manner.

(3) All equipment, including scales and liquid metering devices, shall be of suitable size, design, construction, precision, and accuracy for its intended purpose.

(4) All scales and metering devices shall be tested for accuracy upon installation and at least once a year thereafter, or more frequently as may be necessary to insure their accuracy.

(5) All equipment shall be so constructed and maintained as to prevent lubricants and coolants from becoming unsafe additives in feed components or medicated feed.

(6) All equipment shall be designed, constructed, installed and maintained so as to facilitate inspection and use of cleanout procedure(s).

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 § 225.30

Form FDA 483 observations citing this section, fiscal years 2009–2026 (Veterinary Medicine).

  • Calibration of scales and metering devices 30
  • Equipment capability to produce a medicated feed 24
  • Equipment maintenance & cleanliness 13
  • Equipment suitable for intended purpose 4
  • Properly installed 2
  • Equipment design for inspection and use of cleanout procedures 2

Warning letters citing § 225.30

1 FDA warning letters since 2017 cite this section :

Amendment history

Federal Register documents that created or amended this section.