D R Burton Healthcare LLC
Form 483 issued April 11, 2019 · Farmville, North Carolina
- Inspection
- Apr 8 – Apr 11, 2019
- Investigator
- Nydia E. Colon
- Observations
- 2
- Pages
- 6
- FEI number
- 3012970776
In short: On April 11, 2019, FDA issued a Form 483 with 2 observations to D R Burton Healthcare LLC in Farmville, North Carolina (FEI 3012970776) after an inspection that ran Apr 8 – Apr 11, 2019. The investigator was Nydia E. Colon. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.100 (corrective and preventive action).
At a glance
2 of 2 observations on this 483 concern capa.
Most cited: 21 CFR 820.100(a) (1×) · 820.198(c) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action have…
- 02
Complaints involving the possible failure of a device to meet any of its specifications were…
This inspection in context
Nydia E. Colon
4 documents · 2019–2024
Cites 820.100(a) (corrective and preventive action) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmD R Burton Healthcare LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at D R Burton Healthcare LLC?
FDA listed 2 observations on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.100 (corrective and preventive action). The opening words of each observation are shown on this page.
Who inspected D R Burton Healthcare LLC?
Nydia E. Colon is named on this Form 483, for the inspection of Apr 8 – Apr 11, 2019. Each investigator has a profile showing what they cite most.
When was D R Burton Healthcare LLC inspected by FDA?
The inspection ran Apr 8 – Apr 11, 2019, and the Form 483 is dated April 11, 2019.
How do I get the full Form 483 for D R Burton Healthcare 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.