# FDA 483 - Spintech LLC - June 08, 2022

Source: https://www.keypedia.com/records/483/spintech-llc/ede84f58-6da2-4639-8053-d3a99ecf5ea4

> FDA 483 for Spintech LLC on June 08, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Spintech LLC
- Inspection Date: 2022-06-08
- Product Type: device
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Spintech LLC, a medical device manufacturer in Statesville, NC, revealed nine significant deficiencies in its quality system. The firm failed to validate its manufacturing process for disposable protective masks and lacked essential written procedures for medical device reporting, CAPA, quality audits, and management review. Additionally, issues were noted with supplier agreements, device history records, and distribution records, indicating a broad non-compliance with quality system requirements.

## Related Officers

- [Gamal A. Norton](https://www.keypedia.com/people/gamal-a-norton/6b52c9e6-d579-4994-81ee-e734eb1f0a67)

Company: https://www.keypedia.com/companies/spintech-llc/6d42f20a-e153-459e-9aae-b5c92d11b208

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