FDA Flags Outsourcer for Cybersecurity and Labeling Issues

The FDA cited a drug outsourcing facility in Bethlehem, Penn., for numerous compliance problems including inadequate computer security and lax labeling practices.

The agency issued a Form 483 to U.S. Specialty Formulations following an August inspection in which investigators found the facility lacked adequate computer controls, with no login required for the facility system, allowing for deletion of raw data files including assay test data without leaving an audit trail.

The FDA also faulted the facility’s aseptic processing, finding the procedure allowed insufficient contact time for certain cleaning agents in processing areas. The facility also lacked written pre-cleaning instructions.