Integron, Inc. - Dec. 10, 2018
Issue Date
Dec 10, 2018
Region
Northeast
Category
Device
$117.00
Contact Name
Jeanne M. Pagani
Contact Title
CEO
Address 1
35 Bermar Park
City
Rochester
State
NY
Zip/Postal Code
14624
Country
United States
Inspection Range
Dec 07, 2018 - Dec 10, 2018
Pages
2
First Observation
Software used as part of production has not been adequately validated for its intended use according to an established protocol.
Investigator(s): Joel R. Powers and Matthew D. Schnittker