AVEVA Drug Delivery Systems, Inc. - December 4, 2009
Issue Date
Dec 04, 2009
Region
Southeast
Category
Drug
$117.00
Address 1
3250 Commerce Pkwy
City
Miramar
State
FL
Zip/Postal Code
33025-3907
Country
US
Inspection Range
Oct 22, 2009 - Dec 04, 2009
Pages
12
First Observation
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Investigator(s): Ileana Barreto-Pettit and Dawn M. McCabe