Company: Abbott Laboratories Inc.
Product: Drug products
Date: 10/15/2002

Failure to assure that automated equipment will perform a function satisfactorily during the manufacturing process for your drug products [21 CFR 211.68]. For example,

The _____ process control computer monitoring system that is used to monitor various production and processing operations (e.g., operation conditions, equipment and component status, historical trending of collected data) is not validated to the current corporate standards.

FDA District: Dallas District Office