# FDA WARNING_LETTER - SpineFrontier, Inc. - July 11, 2012

Source: https://www.globalkeysolutions.net/records/warning_letter/spinefrontier-inc/9532f00d-fce5-44ed-9c32-15698e8e8b6d

> FDA WARNING_LETTER for SpineFrontier, Inc. on July 11, 2012. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: SpineFrontier, Inc.
- Inspection Date: 2012-07-11
- Product Type: Devices
- Office Name: Department of Health and Human Services
- Summary: On August 8, 2012, the FDA issued a Warning Letter to SpineFrontier, Inc. following an inspection from May 23 to July 11, 2012. The inspection found that SpineFrontier, a specification developer and repackager of bone fusion devices like the S-LIFT Intervertebral Body Fusion Device, had adulterated devices under 21 U.S.C. § 351(h) due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Key violations included:
1.  **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a))**: CAPAs were not opened as required, e.g., for unmaintained complaints prior to January 2012.
2.  **Failure to investigate nonconformities (21 CFR 820.100(a)(2))**: CAPA investigations were not assigned within the required 30 days, often taking 50-130 days.
3.  **Failure to verify CAPA effectiveness (21 CFR 820.100(a)(4))**: CAPA 103, addressing a device breakage, lacked verification data and similar complaints occurred post-closure.
4.

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Company: https://www.globalkeysolutions.net/companies/spinefrontier-inc/2c027911-065a-410e-b340-9cd846d5d1a7

Office: https://www.globalkeysolutions.net/offices/department-of-health-and-human-services/cecfcda4-4afa-4a1f-a7b7-a020b79f9861