Hologic, Inc. - December 15, 2010
Issue Date
Dec 15, 2010
Region
Northeast
Category
Device
$117.00
Address 1
36 Apple Ridge Rd.
City
Danbury
State
CT
Zip/Postal Code
06810-7301
Country
US
Inspection Range
Dec 08, 2010 - Dec 15, 2010
Pages
3
First Observation
Production processes were not controlled and monitored to ensure that a device conforms to its specifications.
Investigator(s): Edward J. Janik