California Devicemaker Slammed for Labeling Activities, Validation

Pacoima, California-based KDL Precision Molding, a class II and III devicemaker, was hit with a Form 483 for a validation failure and a lack of written procedures for controlling labeling activities.

The agency’s inspection revealed the facility didn’t validate a liquid injection molding machine for use in manufacturing its FemCap birth control devices.

It also didn’t put in place written procedures for controlling FemCap labeling activities, neglecting to document labeling inspections and include primary identification labels in device history records.