Wisconsin Drugmaker Cited for Multiple Repeat Violations

The FDA hit Wisconsin drugmaker MaxPax with a Form 483 for repeat quality violations, some dating as far back as 2006.

A July 2019 inspection revealed that the facility’s quality unit failed to identify that a lot was expired before it was used to manufacture drug products. The agency previously observed similar issues during four previous inspections — in 2006, 2009, 2011 and 2015.

The unit also didn’t approve all procedures or specifications relating to the quality of its drug products, a violation flagged in two separate inspections.

The investigators once again found that the facility didn’t follow written cleaning and maintenance procedures for equipment, including utensils used to manufacture a drug product. Inspections in 2011 and 2015 found the same deficiencies.  The firm also didn’t have cleaning documentation for equipment used to package human drug products.