Berkshire Sterile Manufacturing, LLC - May 23, 2022
Issue Date
May 23, 2022
Region
Northeast
Category
Drug
$117.00
Contact Name
Shawn Kinney
Contact Title
CEO
Address 1
480 Pleasant St.
City
Lee
State
MA
Zip/Postal Code
01238-9265
Inspection Range
May 09, 2022 - May 23, 2022
Pages
3
First Observation
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
Investigator(s): Erik W. Koester