Company: Unit Dose Packaging Inc.
Product: Drug products
Date: 8/29/02
Failure to establish a written procedure to calibrate, inspect, and check automated, mechanical, or electronic equipment used to manufacture drug products to assure proper performance. [21 CFR 211.68 (a)]. Specifically, there is no data to demonstrate that production equipment (two mixers, one filler, a water system) has been properly validated (installation qualification, operational qualification, and performance qualification) as acceptable for its intended uses.
FDA District: Los Angeles District Office
