Olympus Corp. of the Americas - March 10, 2022
Issue Date
Mar 10, 2022
Region
Pacific
Category
Device
$117.00
Contact Name
Daniel G. Scalzo
Contact Title
Vice President, Service Engineering and Repair
Address 1
2400 Ringwood Ave.
City
San Jose
State
CA
Zip/Postal Code
95131-1713
Country
United States
Inspection Range
Feb 22, 2022 - Mar 10, 2022
Pages
8
First Observation
The written MDR Procedure does not include an internal system which provides for timely and effective identification and evaluation of events that may be subject to medical device reporting requirements.
Investigator(s): Kenya Destin and Suzanne M. Healy