21 CFR 111.310 - What are the requirements for the laboratory facilities that you use?

Regulations last checked for updates: May 02, 2025

Title 21 - Food and Drugs last revised: Apr 28, 2025

§ 111.310 - What are the requirements for the laboratory facilities that you use?

You must use adequate laboratory facilities to perform whatever testing and examinations are necessary to determine whether:

(a) Components that you use meet specifications;

(b) In-process specifications are met as specified in the master manufacturing record; and

authority: 21 U.S.C. 321,342,343,371,374,381,393; 42 U.S.C. 264.

source: 72 FR 34942, June 25, 2007, unless otherwise noted.

cite as: 21 CFR 111.310