Swiss American CDMO, LLC - Dec. 19, 2022
Issue Date
Dec 19, 2022
Region
Southwest
Category
Device
$117.00
Contact Name
Lesli M. Earlston
Contact Title
Vice President, Regulatory, Quality, & Compliance
Address 1
2055 Luna Rd.
Address 2
Ste. 126
City
Carrollton
State
TX
Zip/Postal Code
75006-6623
Inspection Range
Dec 13, 2022 - Dec 19, 2022
Pages
5
First Observation
Software used as part of the quality system has not been adequately validated for its intended use according to an established protocol.
Investigator(s): Terri Gibson