All American Responds to 483 Report

BILLINGS, Mont.All American Pharmaceutical received a warning letter from FDA in mid-January, following up on a GMP (good manufacturing practice) inspection and related 483 observation form from August 2010. All American filed a response with FDA on Aug. 13, 2010, to the alleged GMP violations; however, FDA considered the response to be inadequate in several cases.

Specifically, FDA continues to be concerned about appropriate documentation related to master manufacturing records; issuance and use of labels related to batch production records; and possible deficiencies in segregating and identifying containers of product during manufacturing to avoid contamination. As All American did respond that its records have been updated, FDA said it intends to verify the adequacy of master manufacturing records and BPRs during its next inspection.