Exact Medical Manufacturing, Inc. - March 11, 2021
Issue Date
Mar 11, 2021
Region
Northeast
Category
Device
$117.00
Contact Name
Ryan K. Power
Contact Title
Vice President
Address 1
4917 William St.
Address 2
Ste. C
City
Lancaster
State
NY
Zip/Postal Code
14086-3200
Country
United States
Inspection Range
Mar 08, 2021 - Mar 11, 2021
Pages
2
First Observation
Design validation did not ensure the device conforms to defined user needs and intended uses.
Investigator(s): Matthew D. Schnittker