Biogenesis, Inc. - Feb. 2, 2012
Issue Date
Feb 02, 2012
Region
Central
Category
Drug
$117.00
Address 1
296 Washington Ave.
City
Hackensack
State
NJ
Zip/Postal Code
07601-6727
Country
US
Inspection Range
Jan 24, 2012 - Feb 02, 2012
Pages
2
First Observation
Drug product production and control records are not reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.
Investigator(s): Melba T. Rivera Clavell