Abbott hit for failure to validate environmental monitoring system. (Human Drugs).

Validation Times | December 1, 2002 | Copyright

Abbott's Austin, TX, facility was cited in a recent warning letter for failure to maintain records so that data could be used for evaluating drug product quality standards, plus failure to validate environmental monitoring.

Specifically, the Oct. 15 letter stated that monitoring for non-viable particulates in one area of the facility recorded counts "over the action limit," and that no deviation report, investigation, or measure was undertaken in response to this event. Unnamed investigators of the Dallas District inspected the plant Aug. 19-28.

The agency ...

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