IntelGenx Corp.
Form 483 issued February 25, 2022 · Saint-Laurent, Canada
- Inspection
- Feb 21 – Feb 25, 2022
- Investigator
- Gam S. Zamil
- Observations
- 2
- Pages
- 3
- FEI number
- 3005721224
In short: On February 25, 2022, FDA issued a Form 483 with 2 observations to IntelGenx Corp. in Saint-Laurent, Quebec (FEI 3005721224) after an inspection that ran Feb 21 – Feb 25, 2022. The investigator was Gam S. Zamil. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.166 (stability testing).
At a glance
Laboratory controls and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.166 (1×) · 211.68 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Results of stability testing are not used in determining appropriate storage…
- 02
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
This inspection in context
Gam S. Zamil
18 documents · 2016–2024
Cites 211.166 (stability testing) more than any other section. Most of their documents are for sites in New York.
The firmIntelGenx Corp. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.166
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at IntelGenx Corp.?
FDA listed 2 observations on this Form 483, mostly about laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.166 (stability testing). The opening words of each observation are shown on this page.
Who inspected IntelGenx Corp.?
Gam S. Zamil is named on this Form 483, for the inspection of Feb 21 – Feb 25, 2022. Each investigator has a profile showing what they cite most.
When was IntelGenx Corp. inspected by FDA?
The inspection ran Feb 21 – Feb 25, 2022, and the Form 483 is dated February 25, 2022.
How do I get the full Form 483 for IntelGenx Corp.?
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.