Apotex Inc.
Form 483 issued December 16, 2022 · Brantford, Canada
- Investigator
- Taichun Qin
- Observations
- 2
- Pages
- 2
- FEI number
- 3000114091
In short: On December 16, 2022, FDA issued a Form 483 with 2 observations to Apotex Inc. in Brantford, Ontario (FEI 3000114091). The investigator was Taichun Qin. 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
Validation of stability indicating method…
- 02
Completed projects are not signed off and…
This inspection in context
Taichun Qin
35 documents · 2017–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
The firmApotex Inc. 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 Apotex Inc.?
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 Apotex Inc.?
Taichun Qin is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Apotex Inc. inspected by FDA?
This Form 483 is dated December 16, 2022.
How do I get the full Form 483 for Apotex 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.