Pharmaceutics International, Inc. - Sept. 29, 2021
Issue Date
Sep 29, 2021
Region
Central
Category
Drug
$117.00
Contact Name
Kurt R. Nielsen
Contact Title
President/CEO
Address 1
103 Beaver Ct.
City
Cockeysville
State
MD
Zip/Postal Code
21030
Country
United States
Inspection Range
Jul 26, 2021 - Sep 29, 2021
Pages
15
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): Shirshendu K. Deb, Marcellinus Dordunoo, Kathleen Jordan, and Viviana Matta