# FDA 483 - Surgical Principals Inc - October 08, 2019

Source: https://www.keypedia.com/records/483/surgical-principals-inc/3736abc0-2063-405c-9aa8-08475d58722f

> FDA 483 for Surgical Principals Inc on October 08, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Surgical Principals Inc
- Inspection Date: 2019-10-08
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: 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.

## Related Officers

- [investigator](https://www.keypedia.com/people/christopher-s-genther/e71df42c-9adf-4a78-93e5-c364dcc06b35)

Company: https://www.keypedia.com/companies/surgical-principals-inc/a4dc9fc2-b1fd-4dd8-a129-ff60e62b28e1

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822