# FDA 483 - Alphatec Spine, Inc. - February 11, 2010

Source: https://www.keypedia.com/records/483/alphatec-spine-inc/30a2d753-9605-4596-a9ff-d98bf770a838

> FDA 483 for Alphatec Spine, Inc. on February 11, 2010. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alphatec Spine, Inc.
- Inspection Date: 2010-02-11
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Alphatec Spine, Inc., a medical device manufacturer in Carlsbad, CA, was cited for multiple quality system deficiencies during an FDA inspection. Key issues included inadequate medical device reporting (MDR) practices, incomplete design output identification, insufficient process validation for sterilization, and failures in complaint handling and corrective/preventive actions. The inspection revealed a pattern of non-compliance across several critical areas of device manufacturing and quality control.

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- [WARNING_LETTER - 2015-03-13](https://www.keypedia.com/records/warning_letter/alphatec-spine-inc/6a733e1b-4ea8-4d83-a771-694d51d85eea)
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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