Colorado Repackager Cited for Complaint Handling, Nonconforming Product Procedures

The FDA has hit repackager and relabeler 180 Innovations with a Form 483 for failing to establish procedures for receiving, reviewing and evaluating complaints or for rework of nonconforming product procedures, following an inspection of its Lakewood, Colorado site.

The FDA investigator observed that failure investigations were not properly documented and  noted that at least 11 complaints involving the possible failure of a device to meet its performance specifications were not investigated by the firm.

In addition, the facility’s procedures for the rework of nonconforming products didn’t include the requirement that rework and reevaluation activities be documented in the device history record.