Texas Facility Cited for CAPA, Labeling Failures

The FDA hit Texas Eye Prosthetics for failing to fully document corrective and preventive actions at its Houston facility.

The firm also lacked written procedure for labeling including unique device identifiers, the FDA said in a Form 483 inspection report.

The agency also chastised the firm for not completing a device history record containing in-process and final acceptance activities for a prosthetic eye product.