Genzyme Corp. - July 25, 2022
Issue Date
Jul 25, 2022
Region
Northeast
Category
Drug
$117.00
Contact Name
Larry Yudiski
Contact Title
Head of 8 New York Avenue Manufacturing and Interim Site Head
Address 1
68 New York Ave.
City
Framingham
State
MA
Zip/Postal Code
01701-8861
Inspection Range
Jul 18, 2022 - Jul 25, 2022
Pages
2
First Observation
Failure to exercise sufficient controls over computerized systems and failure to have adequate controls to prevent omission of data.
Investigator(s): Sean R. Marcsisin and Daniel L. Zheng