Bristol-Meyers Squibb Co. - April 5, 2017
Issue Date
Apr 05, 2017
Region
Northeast
Category
Drug
$117.00
Contact Name
Luis Maranga
Contact Title
General Manager
Address 1
38 Jackson Rd.
City
Devens
State
MA
Zip/Postal Code
01434
Country
United States
Inspection Range
Mar 16, 2017 - Apr 05, 2017
Pages
1
First Observation
The firm's vendor qualification program is inadequate in that the Quality Unit failed to establish the reliability of the component supplier's report of analyses by performing periodic analytical evaluations.
Investigator(s): Erik W. Koester, Sean R. Marcsisin, and Robert J. Martin