Quality Failures Highlight Warning Letters for Finished Drugmakers

Batches of hastily assembled drug products distributed too soon and failure to document quality systems activities were among a host of GMP issues drugmakers violated, sometimes more than a year after the FDA first expressed concerns about companies’ repeated lapses during inspections.

Companies consistently failed to provide adequate information on their quality system methodology, detailed testing procedures and validation reports, and they ignored significant consumer complaints, according to an analysis of 2015 warning letters issued by FDA’s Office of Manufacturing Quality.

What flummoxed FDA investigators most was that some drug companies showed the same violations, despite the agency expressing concerns previously. For instance, some did not test APIs from suppliers to make sure they met standards, and often had no procedures in place to cull products that didn’t meet specifications.  Problems also were linked to improper monitoring systems, inadequate recording of test results and inadequate cleaning room practices.