Duchesnay Inc.
Form 483 issued October 27, 2023 · Blainville, Canada
- Inspection
- Oct 23 – Oct 27, 2023
- Investigator
- Marcellinus D. Dordunoo
- Observations
- 1
- Pages
- 1
- FEI number
- 3009166000
In short: On October 27, 2023, FDA issued a Form 483 with 1 observation to Duchesnay Inc. in Blainville, Quebec (FEI 3009166000) after an inspection that ran Oct 23 – Oct 27, 2023. The investigator was Marcellinus D. Dordunoo. Most observations concern production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.100(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
This inspection in context
Marcellinus D. Dordunoo
21 documents · 2017–2026
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in Maryland.
The firmDuchesnay Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Duchesnay Inc.?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Duchesnay Inc.?
Marcellinus D. Dordunoo is named on this Form 483, for the inspection of Oct 23 – Oct 27, 2023. Each investigator has a profile showing what they cite most.
When was Duchesnay Inc. inspected by FDA?
The inspection ran Oct 23 – Oct 27, 2023, and the Form 483 is dated October 27, 2023.
How do I get the full Form 483 for Duchesnay Inc.?
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