# FDA 483 - Surgical Technology Laboratories, Inc - December 10, 2021

Source: https://www.keypedia.com/records/483/surgical-technology-laboratories-inc/6dc8337a-f5f4-4f92-8fd6-243feab1364b

> FDA 483 for Surgical Technology Laboratories, Inc on December 10, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Surgical Technology Laboratories, Inc
- Inspection Date: 2021-12-10
- Product Type: device
- Office Name: Atlanta District Office
- Summary: Surgical Technology Laboratories, Inc. in Lugoff, SC, a medical device manufacturer, was inspected by the FDA. The inspection revealed two significant observations concerning inadequate documentation practices. Specifically, the firm failed to properly document corrective and preventive actions and did not adequately maintain device history records, including using obsolete manufacturing record revisions.

## Related Officers

- [investigator](https://www.keypedia.com/people/aigbokhai-a-dirisu/a3dcb5ac-9940-4443-99f2-82537d6e177b)
- [Christopher B. May](https://www.keypedia.com/people/christopher-b-may/b2173a59-d37b-41f1-aa39-eefd854722b8)

Company: https://www.keypedia.com/companies/surgical-technology-laboratories-inc/25637abd-99c9-4147-aa64-5935ca11c2e2

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7