Ohm Laboratories, Inc. - Feb. 5, 2020
Issue Date
Feb 05, 2020
Region
Central
Category
Drug
$117.00
Contact Name
Daryl C. Lesueur
Contact Title
Vice President and Head of North American Operations
Address 1
14 Terminal Rd.
City
New Brunswick
State
NJ
Zip/Postal Code
08901-3616
Country
United States
Inspection Range
Jan 06, 2020 - Feb 05, 2020
Pages
5
First Observation
Investigations of an unexplained discrepancy did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy.
Investigator(s): James R. Birkenstamm, Rose L. Jean-Mary, and Patric C. Klotzbuecher