Karl Storz Endovision, Inc. - Sept. 17, 2021
Issue Date
Sep 17, 2021
Region
Northeast
Category
Device
$117.00
Contact Name
Bruce H. Watkins
Contact Title
President and General Manager
Address 1
91 Carpenter Hill Rd.
City
Charlton
State
MA
Zip/Postal Code
01507-5274
Country
United States
Inspection Range
Aug 24, 2021 - Sep 17, 2021
Pages
4
First Observation
The design history file was not established, does not demonstrate that the design was developed
following the approved design plan and does not demonstrate that the design was developed following the requirements of 21 CFR 820.
Investigator(s): Jeffrey J. Thibodeau