Doro, Inc

FDA inspection history in Ottawa, Canada, 2015 to 2016

1
Close-out
1
Form 483
1
Warning letter

Every document, by year

  • Close-out
  • Form 483
  • Warning letter

2015: one Form 483 and one warning letter; 2016: one close-out letter.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2015–16One Form 483, one warning letter and one close-out letter, at Ottawa, Canada.

Cited most

Across all Doro observations on file

The complete Doro 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

Also: two documents not tied to a site.

Documents

3 on file, newest first
DateDocumentPrice
2016-04-29Close-out Close-out letter$99
2015-11-05483 Form 483$99
2015-03-09Warning letter Warning letter$99

Investigators on these documents

Kathleen S. Tormey (1)

FEI number 3009238346 · most recent document Apr 29, 2016

About Doro, Inc

How many FDA Form 483s has Doro, Inc received?

FDA Intel has 1 Form 483 on file for Doro, Inc; the most recent is dated Nov 5, 2015.

When was Doro, Inc last inspected by FDA?

The most recent FDA inspection document on file for Doro, Inc is a Form 483 dated Nov 5, 2015, for the site in Ottawa, Canada.

What did FDA cite at Doro, Inc?

The regulations cited most in the observations on file for Doro, Inc are 21 CFR 820, 1 time; 21 CFR 820.30(j) (Design controls), 1 time; 21 CFR 820.50(a)(1) (Purchasing controls), 1 time.

Has Doro, Inc received an FDA warning letter?

Yes. FDA Intel has 1 FDA warning letter on file for Doro, Inc; the most recent is dated Mar 9, 2015.

Doro, Inc FDA Inspection History & 483s · FDA Intel