Category: Drug 483s
Inspection date range: 1/24/12-2/2/12
Company: Biogenesis, Inc.
296 Washington Ave.
Hackensack, NJ 07601-6727
Inspector(s): Melba T. Rivera Clavell
Observations: 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.