BLA Enterprises, LLC dba Green Mountain Pharmaceuticals - Dec. 13, 2021
Issue Date
Dec 13, 2021
Region
Southwest
Category
Drug
$117.00
Contact Name
Anne M. Szilagyi
Contact Title
Vice President of Quality
Address 1
12860 W. Cedar Dr.
Address 2
Ste. 201
City
Lakewood
State
CO
Zip/Postal Code
80228-1965
Country
United States
Inspection Range
Dec 03, 2021 - Dec 13, 2021
Pages
4
First Observation
Written records of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.
Investigator(s): Alan P. Kurtzberg