# FDA WARNING_LETTER - Spinetronics, LLC - March 01, 2011

Source: https://www.keypedia.com/records/warning_letter/spinetronics-llc/3a28c6a6-c2d4-44c7-a385-decefa280e71

> FDA WARNING_LETTER for Spinetronics, LLC on March 01, 2011. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Spinetronics, LLC
- Inspection Date: 2011-03-01
- Product Type: Devices
- Office Name: Department of Health and Human Services
- Summary: On February 28 - March 1, 2011, an FDA inspection of Spinetronics, LLC in Coral Springs, Florida, revealed that their Antalgic-Trak device was adulterated and misbranded. The device was adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) and under 21 U.S.C. § 351(f)(1)(B) for lacking marketing clearance or approval.

Violations of QS regulation included:
- Failure to establish and maintain design control procedures (21 CFR 820.30(a)(1)), lacking documentation for design validation, design change controls, risk analysis, or structural testing of embedded software.
- Failure to establish and maintain procedures for finished device acceptance (21 CFR 820.80(d)).
- Failure to establish and maintain purchasing control procedures (21 CFR 820.50), including lack of awareness of contract manufacturer's quality system activities.
- Failure to establish and maintain nonconforming product procedures (21 CFR 820.90(a)).
- Failure to establish and maintain Corrective and Preventive Action (CAPA) procedures (21 CFR 820.100(a)).
- Failure

## Related Officers

- [Director](https://www.keypedia.com/people/edwin-ramos/1d413f36-21ea-4c73-be34-24150f56d273)
- [Consumer Safety Officer](https://www.keypedia.com/people/salvatore-n-randazzo/c5f4bcc1-4880-4fb0-a932-c4823503dadf)

Company: https://www.keypedia.com/companies/spinetronics-llc/2b89c767-fb4d-49af-95e5-baaa78c56263

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