Marcus Research Laboratory, Inc. - Sept. 2, 2022
Issue Date
Sep 02, 2022
Region
Southwest
Category
Drug
$117.00
Contact Name
Richard A. Gilbert
Contact Title
President
Address 1
1820 Delmar Blvd.
City
St. Louis
State
MO
Zip/Postal Code
63103
Inspection Range
Aug 22, 2022 - Sep 02, 2022
Pages
11
First Observation
The overall policy, intentions, and approach to process validation designed to assure that APIs have the identity, strength, quality, and purity they purport or are represented to possess are not adequately in writing and fully followed.
Investigator(s): Jacob G. Lutz, Monica E. Murie, and Michele Perry-Williams