Bristol-Myers Squibb Co. - Jan. 10, 2020
Issue Date
Jan 10, 2020
Region
Northeast
Category
Drug
$117.00
Contact Name
John Cazzolli
Contact Title
Director, Devens Clinical Manufacturing
Address 1
38 Jackson Rd.
City
Devens
State
MA
Zip/Postal Code
01434-4020
Country
United States
Inspection Range
Jan 02, 2020 - Jan 10, 2020
Pages
1
First Observation
The firm's review of audit logs for equipment and instruments that generate cGMP data utilized for drug manufacturing operations is inadequate.
Investigator(s): Lauren Barber, Kathleen Jordan, and Sean R. Marcsisin