Incoming Inspections, Procedure Issues Draw Form 483 for Surgical Design
Surgical Design came out of an FDA inspection with seven Form 483 observations, including one for its incoming inspection procedure.
The company's procedure required it to pull 2 percent of incoming circumcision clamps for lot sampling. However, five of 13 incoming inspection documents reviewed from 2013 to 2014 found inspections at less than 2 percent.
Surgical Design was also rapped for lack of:
- Design control procedures;
- Nonconforming product procedures;
- Management review procedures
- Document control procedures for SOPs; and
- Training records for the quality control/inventory management worker and quality control manager.
The form also notes inadequate CAPA procedures at the Lorton, Va., facility.
The Form 483 is available at www.fdanews.com/12-22-14-Surgicaldesign.pdf.