# FDA 483 - Kentec Medical, Inc - July 30, 2018

Source: https://www.keypedia.com/records/483/kentec-medical-inc/5b953747-711d-4b2a-88ae-d800f6303327

> FDA 483 for Kentec Medical, Inc on July 30, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kentec Medical, Inc
- Inspection Date: 2018-07-30
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Kerrtec Medical, Inc. in Irvine, CA, was inspected regarding its medical device manufacturing operations. The inspection revealed significant deficiencies across its quality system, particularly in corrective and preventive actions, purchasing controls, medical device reporting, and various aspects of design control including verification, validation, and review. These issues indicate a systemic failure to adequately establish and implement procedures crucial for ensuring product quality and safety.

## Related Officers

- [Joshua J. Silvestri](https://www.keypedia.com/people/joshua-j-silvestri/433e29b3-ce5f-44d2-9984-7a6cb61e1824)

Company: https://www.keypedia.com/companies/kentec-medical-inc/84a3c6bd-182a-4acd-bf51-a7482ed87bd7

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6