# FDA 483 - Suture Concepts - December 20, 2021

Source: https://www.keypedia.com/records/483/suture-concepts/b823798b-f896-4eff-9c90-644f54aa6b04

> FDA 483 for Suture Concepts on December 20, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Suture Concepts
- Inspection Date: 2021-12-20
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: Suture Concepts in Beverly, MA, a manufacturer of medical devices, was cited with four observations during an FDA inspection. The inspection revealed deficiencies in process validation, finished device acceptance procedures, statistical rationale for sampling plans, and maintenance of the device master record for their Lead Loop Suture Anchor. These issues indicate a lack of adequate controls over manufacturing processes and quality system documentation.

## Related Officers

- [Fouad Attioui](https://www.keypedia.com/people/fouad-attioui/640028ab-0cdd-43c8-816f-433f19c7ad3d)
- [Sara M. Onyango](https://www.keypedia.com/people/sara-m-onyango/643c6ad3-9747-4bc2-9e8e-72f97b11e659)

Company: https://www.keypedia.com/companies/suture-concepts/2ec37033-0b55-492a-8fd8-afc9847248b5

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94