Polygen Pharmaceuticals, LLC - March 24, 2015
Issue Date
Mar 24, 2015
Region
Northeast
Category
Drug
$117.00
Contact Name
Meena Rani
Contact Title
Director QA & RA
Address 1
41 Mercedes Way
Address 2
Unit 17
City
Edgewood
State
NY
Zip/Postal Code
11717-8834
Country
United States
Inspection Range
Mar 11, 2015 - Mar 24, 2015
Pages
1
First Observation
Control procedures are not established which validate the performance of those manufacturing processes that may be responsbile for causing variability in the characteristics of inprocess material and the drug product.
Investigator(s): Robert C. Horan