Osteotech, Inc., Subsidiary of Medtronic PLC - Aug. 10, 2017
Issue Date
Aug 10, 2017
Region
Central
Category
Device
$117.00
Contact Name
Patrick Francis Malone
Contact Title
Senior Director, Site Leader
Address 1
201 Industrial Way West
City
Eatontown
State
NJ
Zip/Postal Code
07724-2205
Country
United States
Inspection Range
Jul 06, 2017 - Aug 10, 2017
Pages
3
First Observation
Environmental controls do not provide for adequate cleaning of rooms and equipment to ensure aseptic processing.
Investigator(s): Esteban Beltran, Jennifer L. Custodio, and Sarah M. Forney