Surgical Principals Inc – FDA 483, Oct 8, 2019

Surgical Principals Inc. in Tacoma, WA, an initial importer of laparoscopic and hernia mesh devices, was cited for significant deficiencies in its quality system during an FDA inspection. The firm lacked essential written procedures for medical device reporting, complaint handling, corrective and preventive actions, and servicing activities. These observations indicate a fundamental failure to establish and implement critical regulatory requirements for medical device operations.