# FDA 483 - VertiFlex, Inc. - July 25, 2014

Source: https://www.globalkeysolutions.net/records/483/vertiflex-inc/5306f20a-1797-418a-a624-cb76d3323638

> FDA 483 for VertiFlex, Inc. on July 25, 2014. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: VertiFlex, Inc.
- Inspection Date: 2014-07-25
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Vertiflex, Inc. in San Clemente, CA, revealed significant deficiencies in record-keeping for investigational devices. The firm failed to maintain accurate and complete records for PMA data, specifically regarding surgical approach procedures, and exhibited widespread inaccuracies and incompleteness in device accountability and disposition records for explanted and returned devices.

## Related Documents

- [483 - 2016-07-19](https://www.globalkeysolutions.net/records/483/vertiflex-inc/b71bafc4-841e-4813-8149-9e7a109cac31)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/ka-l-wong/e624263d-e2c0-4b80-b5d9-ea84e29baa6b)

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