Hologic, Inc. - Oct. 14, 2022
Issue Date
Oct 14, 2022
Region
Pacific
Category
Device
$117.00
Contact Name
Samuel H. Im
Contact Title
Vice President Quality
Address 1
10210 Genetic Center Dr.
City
San Diego
State
CA
Zip/Postal Code
92121-4362
Inspection Range
Oct 03, 2022 - Oct 14, 2022
Pages
8
First Observation
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury.
Investigator(s): Jenny L. Mccardell and James R. Montero