Doro, Inc
Form 483 issued November 5, 2015 · Ottawa, Canada
- Inspection
- Nov 2 – Nov 5, 2015
- Investigator
- Kathleen S. Tormey
- Observations
- 2
- Pages
- 2
- FEI number
- 3009238346
In short: On November 5, 2015, FDA issued a Form 483 with 2 observations to Doro, Inc in Ottawa, Canada (FEI 3009238346) after an inspection that ran Nov 2 – Nov 5, 2015. The investigator was Kathleen S. Tormey. Most observations concern design controls and production & process controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Design controls and production & process controls account for 2 of 2 observations.
What FDA observed
Preview: the opening words of each observation- 0121 CFR 820.30(j)21 CFR 820
Observation 1: scanned text, readable in the full document.
- 02
The evaluation of potential suppliers was not documented. b)(4) Commercial Confidential Info \ Trade…
This inspection in context
Kathleen S. Tormey
2 documents · 2015–2017
Cites 820 more than any other section. Most of their documents are for sites in Canada.
The firmDoro, Inc history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.30(j)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Doro, Inc?
FDA listed 2 observations on this Form 483, mostly about design controls and production & process controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Doro, Inc?
Kathleen S. Tormey is named on this Form 483, for the inspection of Nov 2 – Nov 5, 2015. Each investigator has a profile showing what they cite most.
When was Doro, Inc inspected by FDA?
The inspection ran Nov 2 – Nov 5, 2015, and the Form 483 is dated November 5, 2015.
How do I get the full Form 483 for Doro, 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.