Berkshire Sterile Manufacturing, Inc. - Oct. 15, 2021
Issue Date
Oct 15, 2021
Region
Northeast
Category
Drug
$117.00
Contact Name
Shawn D. Kinney
Contact Title
President & CEO
Address 1
480 Pleasant St.
City
Lee
State
MA
Zip/Postal Code
01238-9265
Country
United States
Inspection Range
Oct 04, 2021 - Oct 15, 2021
Pages
5
First Observation
Drug product containers were not clean and sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use.
Investigator(s): Mindy M. Chou and Daniel L. Zheng