Cardinal Spine
Form 483 issued November 16, 2016 · Louisville, Kentucky
- Inspection
- Nov 15 – Nov 16, 2016
- Investigator
- Shannon A. Gregory
- Observations
- 2
- Pages
- 2
- FEI number
- 3010039129
In short: On November 16, 2016, FDA issued a Form 483 with 2 observations to Cardinal Spine in Louisville, Kentucky (FEI 3010039129) after an inspection that ran Nov 15 – Nov 16, 2016. The investigator was Shannon A. Gregory. Most observations concern production & process controls and records & documents; the most-cited regulation is 21 CFR 820.80 (receiving, in-process, and finished device acceptance).
At a glance
Production & process controls and records & documents account for 2 of 2 observations.
Most cited: 21 CFR 820.80 (1×) · 820.184 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for acceptance activities have…
- 02
Labels and labeling used for each finished product, lot, or batch, were not sufficiently…
This inspection in context
Shannon A. Gregory
5 documents · 2015–2022
Cites 820.30(a) (design controls) more than any other section. Most of their documents are for sites in Kentucky.
The firmCardinal Spine history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.80
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cardinal Spine?
FDA listed 2 observations on this Form 483, mostly about production & process controls and records & documents. The most-cited regulation is 21 CFR 820.80 (receiving, in-process, and finished device acceptance). The opening words of each observation are shown on this page.
Who inspected Cardinal Spine?
Shannon A. Gregory is named on this Form 483, for the inspection of Nov 15 – Nov 16, 2016. Each investigator has a profile showing what they cite most.
When was Cardinal Spine inspected by FDA?
The inspection ran Nov 15 – Nov 16, 2016, and the Form 483 is dated November 16, 2016.
How do I get the full Form 483 for Cardinal Spine?
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.