# FDA 483 - Alphatec Spine, Inc. - March 13, 2015

Source: https://www.keypedia.com/records/483/alphatec-spine-inc/fc3cd643-1b35-40e0-b04b-8407ee537e06

> FDA 483 for Alphatec Spine, Inc. on March 13, 2015. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alphatec Spine, Inc.
- Inspection Date: 2015-03-13
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Alphatec Spine, Inc. in Carlsbad, CA, revealed significant quality system deficiencies, particularly concerning medical device reporting and design controls. The firm failed to submit numerous malfunction reports for its Illico Screw Extender and lacked proper design validation and history files for acquired spinal implant devices. Additionally, procedures for corrective and preventive actions, design validation, and acceptance activities were found to be inadequately established or defined.

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## Related Officers

- [Scott K. Zika](https://www.keypedia.com/people/scott-k-zika/7f967edd-5151-438b-a0e7-dd1db8a227d1)

Company: https://www.keypedia.com/companies/alphatec-spine-inc/ed7e822c-390b-4aa0-b01d-6455663bbe71

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