ImprimisRx - April 9, 2019
Issue Date
Apr 09, 2019
Region
Central
Category
Drug
$117.00
Contact Name
Pramod K. Sharma
Contact Title
Vice President, Quality
Address 1
1705 US Highway 46
Address 2
Ste. 4
City
Ledgewood
State
NJ
Zip/Postal Code
07852
Country
United States
Inspection Range
Mar 25, 2019 - Apr 09, 2019
Pages
1
First Observation
The ISO 7 Filling Room is not adequately constructed to ensure aseptic processing conditions.
Investigator(s): Nancy F. Scheraga and Jay T. Wong