# FDA 483 - Kinamed Inc - February 12, 2020

Source: https://www.keypedia.com/records/483/kinamed-inc/ccbdf94a-3272-4496-b2d3-c89040d5bc69

> FDA 483 for Kinamed Inc on February 12, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kinamed Inc
- Inspection Date: 2020-02-12
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Kinamed Inc., a medical device manufacturer in Camarillo, CA, was inspected by the FDA. The inspection revealed a significant issue with the firm's design control procedures, specifically regarding the inadequate documentation of design review results for a key product. This indicates a need for improved adherence to established quality system requirements for design history files.

## Related Officers

- [investigator](https://www.keypedia.com/people/sarah-a-hassas/4f142d54-fc28-4bd5-82ad-7e6fa443688c)

Company: https://www.keypedia.com/companies/kinamed-inc/952c9674-441f-43ae-887a-5d9124290519

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