Devicor Medical Products Inc
Form 483 issued August 1, 2016 · Cincinnati, Ohio
- Inspection
- Jul 19 – Aug 1, 2016
- Investigator
- Teresa K. Kastner
- Observations
- 3
- Pages
- 6
- FEI number
- 3008492462
In short: On August 1, 2016, FDA issued a Form 483 with 3 observations to Devicor Medical Products Inc in Cincinnati, Ohio (FEI 3008492462) after an inspection that ran Jul 19 – Aug 1, 2016. The investigator was Teresa K. Kastner. Most observations concern design controls and cAPA.
At a glance
Design controls and capa account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
Results of the design risk analysis…
- 02
Procedures for corrective and preventive action have…
- 03
Document control procedures have…
This inspection in context
Teresa K. Kastner
6 documents · 2015–2018
Cites 820.30(g) (design controls) more than any other section. Most of their documents are for sites in Ohio.
The firmDevicor Medical Products Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30(g)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Devicor Medical Products Inc?
FDA listed 3 observations on this Form 483, mostly about design controls, cAPA and records & documents. The opening words of each observation are shown on this page.
Who inspected Devicor Medical Products Inc?
Teresa K. Kastner is named on this Form 483, for the inspection of Jul 19 – Aug 1, 2016. Each investigator has a profile showing what they cite most.
When was Devicor Medical Products Inc inspected by FDA?
The inspection ran Jul 19 – Aug 1, 2016, and the Form 483 is dated August 1, 2016.
How do I get the full Form 483 for Devicor Medical Products Inc?
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.