Patheon Inc.
Form 483 issued February 17, 2023 · Whitby, Canada
- Inspection
- Feb 13 – Feb 17, 2023
- Investigators
- Michele Gottshall· Truong X. Nguyen
- Observations
- 1
- Pages
- 1
- FEI number
- 3003516812
In short: On February 17, 2023, FDA issued a Form 483 with 1 observation to Patheon Inc. in Whitby, Ontario (FEI 3003516812) after an inspection that ran Feb 13 – Feb 17, 2023. The investigators were Michele Gottshall and Truong X. Nguyen. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.165(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
This inspection in context
Michele Gottshall
12 documents · 2020–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmPatheon Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.165(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Patheon Inc.?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Patheon Inc.?
Michele Gottshall and Truong X. Nguyen are named on this Form 483, for the inspection of Feb 13 – Feb 17, 2023. Each investigator has a profile showing what they cite most.
When was Patheon Inc. inspected by FDA?
The inspection ran Feb 13 – Feb 17, 2023, and the Form 483 is dated February 17, 2023.
How do I get the full Form 483 for Patheon 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.