bioMerieux, Inc. - June 14, 2013
Issue Date
Jun 14, 2013
Region
Southeast
Category
Device
$117.00
Address 1
100 Rodolphe St.
City
Durham
State
NC
Zip/Postal Code
27712-9402
Country
US
Inspection Range
Jun 04, 2013 - Jun 14, 2013
Pages
9
First Observation
Production processes were not controlled and monitored to ensure that a device conforms to its specifications.
Investigator(s): Claudette D. Brooks and Sean T. Creighton