FloSpine, LLC
Form 483 issued December 13, 2019 · Boca Raton, Florida
- Inspection
- Dec 9 – Dec 13, 2019
- Investigator
- David M. Wilkinson
- Observations
- 1
- Pages
- 3
- FEI number
- 3011513267
In short: On December 13, 2019, FDA issued a Form 483 with 1 observation to FloSpine, LLC in Boca Raton, Florida (FEI 3011513267) after an inspection that ran Dec 9 – Dec 13, 2019. The investigator was David M. Wilkinson. Most observations concern management controls; the most-cited regulation is 21 CFR 820.22 (quality audit).
At a glance
1 of 1 observations on this 483 concern management controls.
Most cited: 21 CFR 820.22 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Quality audits have not…
This inspection in context
David M. Wilkinson
7 documents · 2018–2025
Cites 820.198(a) (complaint files) more than any other section. Most of their documents are for sites in Florida.
The firmFloSpine, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at FloSpine, LLC?
FDA listed 1 observation on this Form 483, mostly about management controls. The most-cited regulation is 21 CFR 820.22 (quality audit). The opening words of each observation are shown on this page.
Who inspected FloSpine, LLC?
David M. Wilkinson is named on this Form 483, for the inspection of Dec 9 – Dec 13, 2019. Each investigator has a profile showing what they cite most.
When was FloSpine, LLC inspected by FDA?
The inspection ran Dec 9 – Dec 13, 2019, and the Form 483 is dated December 13, 2019.
How do I get the full Form 483 for FloSpine, LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.