ConMed Corporation

FDA inspection history in Utica, New York, 2003 to 2020

1
Form 483
1
Close-out
1
Warning letter

Every document, by year

  • Form 483
  • Close-out
  • Warning letter

2003: one warning letter; 2016: one close-out letter; 2020: one Form 483.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2003One warning letter, at Utica, New York.
  2. 2016One close-out letter, at Utica, New York.
  3. 2020One Form 483, at Utica, New York.

Cited most

Across all ConMed observations on file

The complete ConMed file.

All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.

$297

The price of the documents, added to your cart together

Sites

Documents

3 on file, newest first
DateDocumentPrice
2020-09-22483 Form 483$99
2016-08-01Close-out Close-out letter$99
2003-05-08Warning letter Warning letter$99

Investigators on these documents

Sara M. Onyango (1)Wendy M. Stone (1)

FEI number 3001451571 · most recent document Sep 22, 2020

About ConMed Corporation

How many FDA Form 483s has ConMed Corporation received?

FDA Intel has 1 Form 483 on file for ConMed Corporation; the most recent is dated Sep 22, 2020.

When was ConMed Corporation last inspected by FDA?

The most recent FDA inspection document on file for ConMed Corporation is a Form 483 dated Sep 22, 2020, for the site in Utica, New York.

What did FDA cite at ConMed Corporation?

The regulations cited most in the observations on file for ConMed Corporation are 21 CFR 803.50 (If I am a manufacturer, what reporting requirements apply to me?), 1 time; 21 CFR 820.198 (Complaint files), 1 time.

Has ConMed Corporation received an FDA warning letter?

Yes. FDA Intel has 1 FDA warning letter on file for ConMed Corporation; the most recent is dated May 8, 2003.