S and B Pharma, LLC dba Alkem Laboratories - Sept. 14, 2022
Issue Date
Sep 14, 2022
Region
Southwest
Category
Drug
$117.00
Contact Name
Rakesh Bhushan Tlipathi
Contact Title
Site Head
Address 1
1733 Gilsinn Lane
City
Fenton
State
MO
Zip/Postal Code
63026-2000
Inspection Range
Sep 06, 2022 - Sep 14, 2022
Pages
3
First Observation
Written procedures were not established and followed that describe the in-process controls, and tests, or examinations to be conducted on appropriate samples of in-process materials of each batch to assure batch uniformity and integrity of drug products.
Investigator(s): Matthew Schuckmann