Company: B. Braun Medical Inc.
Date: 9/17/01
Product: Disposable IV sets
Failure to validate computer software used to (1) control the Eto sterilization process, for example, _____ cycles, and (2) control the _____ _____) employed in the manufacture of disposable IV sets, to ensure the software will perform for its intended use. 21 CFR 820.70(i).
FDA District: Philadelphia