# FDA 483 - VertiFlex, Inc. - July 19, 2016

Source: https://www.globalkeysolutions.net/records/483/vertiflex-inc/b71bafc4-841e-4813-8149-9e7a109cac31

> FDA 483 for VertiFlex, Inc. on July 19, 2016. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: VertiFlex, Inc.
- Inspection Date: 2016-07-19
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: VertiFlex, Inc., a medical device manufacturer in San Clemente, CA, was inspected by the FDA. The inspection revealed that device history records were not adequately maintained, specifically noting incomplete rework forms lacking required evaluation information. This indicates a deficiency in the firm's documentation practices.

## Related Documents

- [483 - 2014-07-25](https://www.globalkeysolutions.net/records/483/vertiflex-inc/5306f20a-1797-418a-a624-cb76d3323638)

## Related Officers

- [Jocelyn E. Massey](https://www.globalkeysolutions.net/people/jocelyn-e-massey/4335ffa9-e62c-4139-ba24-fad4845d60c4)

Company: https://www.globalkeysolutions.net/companies/vertiflex-inc/3bf3ef7e-e14e-4bbc-9cd8-d9c99669b230

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