# FDA 483 - Alphatec Spine, Inc. - December 13, 2010

Source: https://www.keypedia.com/records/483/alphatec-spine-inc/70ecf8f2-377d-407f-abed-45917aee0dd5

> FDA 483 for Alphatec Spine, Inc. on December 13, 2010. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alphatec Spine, Inc.
- Inspection Date: 2010-12-13
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Alphatec Spine, Inc. in Carlsbad, CA, a medical device manufacturer, received an FDA Form 483 citing significant quality system deficiencies. These included inadequate validation of sterilization processes, uncontrolled production leading to device specification non-conformance, and failures in corrective and preventive action procedures. The inspection also highlighted lapses in MDR reporting, management review frequency, equipment calibration, and personnel training documentation.

## Related Documents

- [483 - 2010-02-11](https://www.keypedia.com/records/483/alphatec-spine-inc/30a2d753-9605-4596-a9ff-d98bf770a838)
- [483 - 2015-03-13](https://www.keypedia.com/records/483/alphatec-spine-inc/fc3cd643-1b35-40e0-b04b-8407ee537e06)
- [WARNING_LETTER - 2015-03-13](https://www.keypedia.com/records/warning_letter/alphatec-spine-inc/6a733e1b-4ea8-4d83-a771-694d51d85eea)
- [483 - 2017-04-19](https://www.keypedia.com/records/483/alphatec-spine-inc/30f0a520-5674-4165-ae62-46bfc00c1e69)

## Related Officers

- [investigator](https://www.keypedia.com/people/courtney-n-long/32118415-bc77-4ac2-8f90-947e43cf10ff)

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