SpineNet LLC
Form 483 issued October 9, 2019 · Winter Park, Florida
- Inspection
- Oct 8 – Oct 9, 2019
- Investigator
- Joshua J. Silvestri
- Observations
- 3
- Pages
- 4
- FEI number
- 3006755626
In short: On October 9, 2019, FDA issued a Form 483 with 3 observations to SpineNet LLC in Winter Park, Florida (FEI 3006755626) after an inspection that ran Oct 8 – Oct 9, 2019. The investigator was Joshua J. Silvestri. Most observations concern design controls and management controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
2 of 3 observations on this 483 concern design controls.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for design input have…
- 02
Procedures for design validation have…
- 03
Procedures for quality audits have…
This inspection in context
Joshua J. Silvestri
8 documents · 2019–2025
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Georgia.
The firmSpineNet LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.30(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at SpineNet LLC?
FDA listed 3 observations on this Form 483, mostly about design controls and management controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected SpineNet LLC?
Joshua J. Silvestri is named on this Form 483, for the inspection of Oct 8 – Oct 9, 2019. Each investigator has a profile showing what they cite most.
When was SpineNet LLC inspected by FDA?
The inspection ran Oct 8 – Oct 9, 2019, and the Form 483 is dated October 9, 2019.
How do I get the full Form 483 for SpineNet 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.