FDA Raps Contract Manufacturer for Validation Failures

The FDA has cited Relucent Plastic Solutions for validation failures, lax corrective and preventive action (CAPA) procedures, and failure to control product at its facility in Erie, Colo.

In an inspection, the agency found that the firm had not validated the injection-molding process for certain products, and it lacked documentation of installation qualification activities for its injection-molding machines.

In addition, seven CAPAs reviewed by the FDA investigator lacked required information, including evidence to show that the corrective actions were effective.