# FDA WARNING_LETTER - Spinal Solutiions, LLC - September 15, 2011

Source: https://www.keypedia.com/records/warning_letter/spinal-solutiions-llc/dfe004cc-e76c-46f2-99e0-c01a8b8d33fe

> FDA WARNING_LETTER for Spinal Solutiions, LLC on September 15, 2011. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Spinal Solutiions, LLC
- Inspection Date: 2011-09-15
- Product Type: Devices
- Office Name: Los Angeles District Office
- Summary: On January 19, 2012, the FDA issued a Warning Letter to Spinal Solutions, LLC, following an inspection from July 11 to September 15, 2011. The inspection found that Spinal Solutions, a repacker/kit assembler of spinal implant systems and own-label distributor of spinal implant instruments, was manufacturing adulterated devices under Section 501(h) of the Act, as their manufacturing, packing, storage, or installation methods did not conform to Quality System (QS) regulation (21 CFR Part 820).

The letter detailed numerous QS violations, including:
- Failure to establish and maintain procedures for corrective and preventive action (21 CFR 820.100(a)).
- Failure to establish and maintain procedures to control nonconforming product (21 CFR 820.90(a)).
- Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints (21 CFR 820.198(a)).
- Failure to establish and maintain adequate procedures for purchasing controls, including supplier agreements and an Approved Suppliers List (21 CFR 820.50).
- Failure to establish and maintain procedures for finished device acceptance (21 CFR 820.80(d)) and incoming product acceptance (21 CFR 820.80(b)).
- Failure to establish

## Related Officers

- [Director](https://www.keypedia.com/people/alonza-e-cruse/650e3631-3f99-45f7-863e-3a35c44be485)

Company: https://www.keypedia.com/companies/spinal-solutiions-llc/63ec97eb-d9aa-415c-8b47-0c7553f208db

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