Auxigen Pharmaceutical, LLC – FDA 483, Jul 8, 2014

The FDA Form 483 details numerous deficiencies observed during an inspection of a pharmaceutical manufacturing facility.

**Batch Production and Control Records:** * Batch records for acetaminophen 500mg and aspirin 81mg manufactured between (b)(4) were incomplete. * The batch record numbering system (utilizing (b)(4)) did not distinguish between lots manufactured on different days within the same month, leading to identical lot numbers for products manufactured on separate dates (e.g., acetaminophen 500mg lot 011414A415). * Records lacked reconciliation of actual and theoretical yields for components, bulk drug product, container closures, and labeling. * Significant manufacturing and packaging steps (dispensing, compression, packaging line setup/clearance) were not documented. * Batch records did not include descriptions and lot numbers for unique lots of containers and closures, results of packaged and labeled product review, a list of major equipment used, in-process or laboratory control test results, or inspection results of manufacturing/packaging areas. * Line clearance activities were not performed or documented. * Weights and measures of components used were not recorded. * A batch record for acetaminophen 500mg lot 011414B488 was not completed.

**Process Control and Validation:** * Control procedures were not established to monitor output and validate manufacturing processes for