Centurion Medical Products Corporation
Form 483 issued September 21, 2015 · Howell, Michigan
- Inspection
- Sep 9 – Sep 21, 2015
- Investigator
- Sargum C. Sood
- Observations
- 1
- Pages
- 3
- FEI number
- 1824619
In short: On September 21, 2015, FDA issued a Form 483 with 1 observation to Centurion Medical Products Corporation in Howell, Michigan (FEI 1824619) after an inspection that ran Sep 9 – Sep 21, 2015. The investigator was Sargum C. Sood. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.90 (nonconforming product).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 820.90(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures have not been established to control product that does not conform to specified requirements. Note…
This inspection in context
Sargum C. Sood
5 documents · 2015–2017
Cites 820.30(d) (design controls) more than any other section. Most of their documents are for sites in Indiana.
The firmCenturion Medical Products Corporation history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.90(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Centurion Medical Products Corporation?
FDA listed 1 observation on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.90 (nonconforming product). The opening words of each observation are shown on this page.
Who inspected Centurion Medical Products Corporation?
Sargum C. Sood is named on this Form 483, for the inspection of Sep 9 – Sep 21, 2015. Each investigator has a profile showing what they cite most.
When was Centurion Medical Products Corporation inspected by FDA?
The inspection ran Sep 9 – Sep 21, 2015, and the Form 483 is dated September 21, 2015.
How do I get the full Form 483 for Centurion Medical Products Corporation?
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.