Centurion Medical Products Corporation
Form 483 issued August 20, 2019 · Howell, Michigan
- Inspection
- Aug 5 – Aug 20, 2019
- Investigator
- Thomas A. Peter
- Observations
- 5
- Pages
- 8
- FEI number
- 1824619
In short: On August 20, 2019, FDA issued a Form 483 with 5 observations to Centurion Medical Products Corporation in Howell, Michigan (FEI 1824619) after an inspection that ran Aug 5 – Aug 20, 2019. The investigator was Thomas A. Peter. Most observations concern production & process controls and cAPA; the most-cited regulation is 21 CFR 820.70 (production and process controls).
At a glance
4 of 5 observations on this 483 concern production & process controls.
What FDA observed
Preview: the opening words of each observation- 01
Procedures to control environmental conditions have…
- 02
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 03
Software used as pail of production has not been adequately validated for its intended use according…
- 04
Procedures for acceptance activities have…
This inspection in context
Thomas A. Peter
9 documents · 2011–2019
Cites 820.30(a) (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 820.70(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Centurion Medical Products Corporation?
FDA listed 5 observations on this Form 483, mostly about production & process controls and cAPA. The most-cited regulation is 21 CFR 820.70 (production and process controls). The opening words of each observation are shown on this page.
Who inspected Centurion Medical Products Corporation?
Thomas A. Peter is named on this Form 483, for the inspection of Aug 5 – Aug 20, 2019. Each investigator has a profile showing what they cite most.
When was Centurion Medical Products Corporation inspected by FDA?
The inspection ran Aug 5 – Aug 20, 2019, and the Form 483 is dated August 20, 2019.
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.