Berkshire Sterile Manufacturing, Inc. - Oct. 10, 2018
Issue Date
Oct 10, 2018
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
Country
United States
Inspection Range
Sep 24, 2018 - Oct 10, 2018
Pages
5
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): Rajiv R. Srivastava