Virginia Specification Developer Nailed for Repeat Violations

The FDA hit Midlothian, Virginia specification developer Med-Tex with a Form 483 over repeat failures to establish procedures at its facility.

An agency inspection revealed repeated failures to document, define and implement procedures for corrective and preventive actions (CAPAs) and purchasing controls. The company also failed to define or implement procedures for nonconforming products or materials.

The agency previously noted Med-Tex’s procedural failures for CAPAs and purchasing controls during a February 2017 inspection.