# FDA 483 - Kapstone Manufacturing LLC - November 16, 2021

Source: https://www.keypedia.com/records/483/kapstone-manufacturing-llc/0f295704-bf0c-48b1-9daf-4d2e2b6a16e9

> FDA 483 for Kapstone Manufacturing LLC on November 16, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kapstone Manufacturing LLC
- Inspection Date: 2021-11-16
- Product Type: device
- Office Name: Atlanta District Office
- Summary: Kapstone Manufacturing LLC, a contract manufacturer in Charlotte, NC, was inspected by the FDA from November 8-16, 2021. The inspection revealed significant deficiencies across its quality system, including inadequate process validation, lack of control over nonconforming products, and insufficient procedures for labeling, CAPA, supplier management, and training. These issues indicate a systemic failure to adhere to established quality system regulations for medical devices.

## Related Officers

- [Gamal A. Norton](https://www.keypedia.com/people/gamal-a-norton/6b52c9e6-d579-4994-81ee-e734eb1f0a67)
- [investigator](https://www.keypedia.com/people/aigbokhai-a-dirisu/a3dcb5ac-9940-4443-99f2-82537d6e177b)

Company: https://www.keypedia.com/companies/kapstone-manufacturing-llc/50f3defe-aca7-4487-86f7-1ebf00800e4b

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