Date: 25 May 11
Link FDA 483 (PDF - New Window)
Observation
b. During routine operations, if there is an alarm event (e.g., time out, high and low temperature for washing and siliconizing, instrument line failure, jacket gauge failure and steam header failure) during the wash and depyrogenation process, the [redacted] Stopper Washer captures the alarm condition via a print out and the data is
Saturday, 10 December 2011
FDA Warning Letter - Alarm Management
Posted on 02:17 by Unknown
Subscribe to:
Post Comments (Atom)
0 comments:
Post a Comment