Smiths Medical ASD, Inc. - June 9, 2023
Issue Date
Jun 09, 2023
Region
Central
Category
Device
$117.00
Contact Name
James J. Vegel
Contact Title
Vice President of Quality
Address 1
3400 Grenada Ave. N.
City
Oakdale
State
MN
Zip/Postal Code
55128-3551
Inspection Range
May 22, 2023 - Jun 09, 2023
Pages
5
First Observation
Process control procedures that describe any process controls necessary to ensure conformance to specifications have not been adequately established.
Investigator(s): Tyler R. Courtney and Albert L. Nguyen