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

Source: https://www.globalkeysolutions.net/records/warning_letter/alphatec-spine-inc/6a733e1b-4ea8-4d83-a771-694d51d85eea

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

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## Details

- Record Type: WARNING_LETTER
- Company Name: Alphatec Spine, Inc.
- Inspection Date: 2015-03-13
- Product Type: Devices
- Office Name: Los Angeles District Office
- Summary: An FDA inspection of Alphatec Spine, Inc. from February 4 to March 13, 2015, revealed that their sterile pedicle screw implants and stainless steel instruments are adulterated under 21 U.S.C. § 321(h) due to non-conformity with Quality System regulation (21 CFR Part 820).

Key violations include:
1.  **Failure to validate design under actual/simulated use (21 CFR 820.30(g)):** The Illico MIS Screw Extension (SE) System's (b)(4) design was not validated, despite 28 MDR-reportable complaints.
2.  **Failure to establish a design history file (21 CFR 820.30(j)):** No DHF exists for the (b)(4) spinal implant device acquired around (b)(4) prior to that date, hindering failure investigations and recalls.
3.  **Failure to maintain a device history record (21 CFR 820.184):** Incomplete DHRs for the acquired (b)(4) device, impacting failure investigations and recall efforts.
4.  **Failure to adequately document corrective and preventive actions (21 CFR 820.100(b)):** No records of a previous recall for the (b)(4) device, including disposition

## Related Officers

- [Director](https://www.globalkeysolutions.net/people/alonza-e-cruse/650e3631-3f99-45f7-863e-3a35c44be485)
- [Chief. Environmental Program Manager I](https://www.globalkeysolutions.net/people/david-mazzera/7fdf231f-4a08-4f88-b6f9-cc9b9b04eaea)

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

Office: https://www.globalkeysolutions.net/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b