Suture Concepts - Dec. 20, 2021
Issue Date
Dec 20, 2021
Region
Northeast
Category
Device
$117.00
Contact Name
William Gorman
Contact Title
Quality Director
Address 1
100 Cummings Ctr.
Address 2
Ste. 348C
City
Beverly
State
MA
Zip/Postal Code
01915-6136
Country
United States
Inspection Range
Dec 14, 2021 - Dec 20, 2021
Pages
5
First Observation
Procedures for monitoring and control of process parameters for a validated process have not been
adequately established.
Investigator(s): Fouad Attioui and Sara M. Onyango