Aarkish Pharmaceuticals NJ, Inc. - Aug. 18, 2022
Issue Date
Aug 18, 2022
Region
Central
Category
Drug
$117.00
Contact Name
Atul Mehta
Contact Title
President, Co-Chairman, Co-Founder
Address 1
8 Commerce Rd.
City
Fairfield
State
NJ
Zip/Postal Code
07004-1602
Inspection Range
Aug 08, 2022 - Aug 18, 2022
Pages
12
First Observation
Batch production and control records for each batch of drug product produced do not include an accurate reproduction of the appropriate master production or control record which was checked for accuracy, dated and signed.
Investigator(s): Karen A. Briggs, Jessica S. Estriplet, and Junho Pak