OSO BioPharmaceuticals Manufacturing, LLC - June 5, 2015
Issue Date
Jun 05, 2015
Region
Southwest
Category
Device
$117.00
Contact Name
James M. Boyer
Contact Title
Senior Vice President Drug Manufacturing
Address 1
4200, 4272 & 4240 Balloon Park Rd. and 4401 Alexander Blvd. NE
City
Albuquerque
State
NM
Zip/Postal Code
87107
Country
United States
Inspection Range
Jun 01, 2015 - Jun 05, 2015
Pages
2
First Observation
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Investigator(s): Erika V. Butler, Zachery L. Miller, and Roger F. Zabinski