Acuity Surgical Devices, LLC - May 29, 2019
Issue Date
May 29, 2019
Region
Southwest
Category
Device
$117.00
Contact Name
Charlie Forton
Contact Title
Director of Engineering & Regulatory Affairs
Address 1
8710 N. Royal Ln.
City
Irving
State
TX
Zip/Postal Code
75063 - 2539
Country
United States
Inspection Range
May 14, 2019 - May 20, 2019
Pages
3
First Observation
Quality audits were not performed at defined intervals to determine whether the quality system activities and results comply with quality system procedures.
Investigator(s): Jeremy L. Stukes