ConMed Corporation
Form 483 issued September 22, 2020 · Utica, New York
- Inspection
- Sep 9 – Sep 22, 2020
- Investigators
- Sara M. Onyango· Wendy M. Stone
- Observations
- 2
- Pages
- 4
- FEI number
- 3001451571
In short: On September 22, 2020, FDA issued a Form 483 with 2 observations to ConMed Corporation in Utica, New York (FEI 3001451571) after an inspection that ran Sep 9 – Sep 22, 2020. The investigators were Sara M. Onyango and Wendy M. Stone. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.198 (complaint files).
At a glance
2 of 2 observations on this 483 concern capa.
Most cited: 21 CFR 820.198 (1×) · 803.50 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Complaints involving the possible failure of a device to meet any of its specifications were…
- 02
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
This inspection in context
Sara M. Onyango
9 documents · 2019–2026
Cites 820.30(f) (design controls) more than any other section. Most of their documents are for sites in Massachusetts.
The firmConMed Corporation history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.198
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ConMed Corporation?
FDA listed 2 observations on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected ConMed Corporation?
Sara M. Onyango and Wendy M. Stone are named on this Form 483, for the inspection of Sep 9 – Sep 22, 2020. Each investigator has a profile showing what they cite most.
When was ConMed Corporation inspected by FDA?
The inspection ran Sep 9 – Sep 22, 2020, and the Form 483 is dated September 22, 2020.
How do I get the full Form 483 for ConMed 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.