FDA Cites Sterile Drugmaker Over Sanitation, Complaints and Product Discrepancies

The FDA flagged Horizon Pharmaceuticals for failure to follow sanitation procedures, insufficient investigations into customer complaints and inadequate reviews of product discrepancies, among other issues.

The agency issued a Form 483 after an inspection in late July and early August revealed that Horizon’s facility in Riviera Beach, Florida failed to follow proper procedures to prevent microbiological contamination of sterile drug products. 

The firm also failed to thoroughly review unexplained discrepancies or batch failures.  An investigation into certain out-of-specification results lacked an evaluation of equipment and a water analysis.