Warning letter

Spinetronics, LLC [ARCHIVED]: warning letter of Jul 25, 2011

FDA warning letter 183812 · Florida District Office

Key facts

Reference number 183812
Company Spinetronics, LLC [ARCHIVED]
Subject CGMP/QSR/Medical Devices/Adulterated/Misbranded
Issue date Jul 25, 2011
Posted date Jul 25, 2011
Issuing office Florida District Office
Product type Devices
CFR sections cited 807.81(a)(3)(ii), 807.81(b), 803, 803.17, 820
Inspection city Coral Springs
Inspection ZIP 33065
Inspection start date Feb 28, 2011
Letter on fda.gov web.archive.org

At a glance

  • 1–9 CFR sections cited
  • OAI Linked inspection classification
  • Yes Form FDA 483 issued

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA warning letters

FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.

Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date:

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