Carnegie Pharmaceuticals, LLC - Sept. 3, 2020
Issue Date
Sep 03, 2020
Region
Central
Category
Drug
$117.00
Contact Name
Rakesh Grover
Contact Title
President and CEO
Address 1
600 Delran Pkwy.
Address 2
Ste. C
City
Delran
State
NJ
Zip/Postal Code
08075-1255
Country
United States
Inspection Range
Aug 24, 2020 - Sep 03, 2020
Pages
2
First Observation
Control procedures are not established which monitor the output and demonstrate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
Investigator(s): Frederick Razzaghi