SISU Global Health - June 27, 2019
Issue Date
Jun 27, 2019
Region
Central
Category
Device
$117.00
Contact Name
Carolyne R. Yarina
Contact Title
Chief Executive Officer
Address 1
2720 Sisson St.
Address 2
2nd Floor
City
Baltimore
State
MD
Zip/Postal Code
21211-3006
Country
United States
Inspection Range
Jun 24, 2019 - Jun 27, 2019
Pages
4
First Observation
Software used as part of the quality system has not been validated for its intended use according to an established protocol.
Investigator(s): Jude C. Dike