Dextrum Laboratories, Inc. - July 18, 2023
Issue Date
Jul 18, 2023
Region
Southwest
Category
Drug
$117.00
Contact Name
Mirta I. Riesgo
Contact Title
President
Address 1
6993 NW. 82nd Ave.
Address 2
Ste. 20
City
Miami
State
FL
Zip/Postal Code
33166-2782
Inspection Range
Jul 10, 2023 - Jul 18, 2023
Pages
5
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 inprocess material and the drug product.
Investigator(s): Samantha E. Cleek, J'Maica J. Hunter, and Joanne E. King