Company: Pharmaceutical Distribution Systems
Date: 01/03/2002
Product: Drug products
Failure to exercise appropriate controls over and to routinely calibrate, inspect, or check automatic, mechanical, or electronic equipment used in the manufacturing, processing, and packaging of a drug product according to a written program designed to assure proper performance (21 CFR 211.68) in that, the installation qualification (IQ), operational qualification (OQ), or performance qualification (PQ), for the _____ was not performed.
FDA District: Baltimore District Office
