InvaGen Pharmaceuticals, Inc. - Dec. 6, 2019
Issue Date
Dec 06, 2019
Region
Northeast
Category
Drug
$117.00
Contact Name
Dwight D. Hanshew Jr.
Contact Title
Vice President & Head of Quality, North America
Address 1
7 Oser Ave.
City
Hauppauge
State
NY
Zip/Postal Code
11788-3811
Country
United States
Inspection Range
Dec 02, 2019 - Dec 06, 2019
Pages
4
First Observation
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength of each active ingredient prior to release.
Investigator(s): Jose O. Hernandez and Ganesh N. Joshi