FDAnews Device Daily Bulletin
Medical Devices / Inspections and Audits

Texas Device Manufacturer Cited for Document Controls

Dec. 3, 2018

Winfield Laboratories was taken to task by the FDA for deficient document controls observed at its Richardson, Texas facility during a September inspection, earning itself a Form 483.

The firm didn’t establish a procedure to control all quality system documents and acknowledged that it had failed to put one in place.

The company also lacked change control records to show certain procedures had been reviewed and approved, the inspector found.

View today's stories