Dextrum Laboratories, Inc. - July 10, 2012
Issue Date
Jul 10, 2012
Region
Southeast
Category
Drug
$117.00
Address 1
6993 Nw 82nd Ave.
Address 2
Ste. 20
City
Miami
State
FL
Zip/Postal Code
33166-2782
Country
US
Inspection Range
Jul 02, 2012 - Jul 10, 2012
Pages
4
First Observation
Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and drug product.
Investigator(s): Ileana Barreto-Pettit