Niagara Pharmaceuticals, Inc
FDA inspection history in Dundas, Canada, 2022
- 1
- Form 483
Every document, by year
- Form 483
2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022One Form 483, at Dundas, Canada.
Cited most
Across all Niagara Pharmaceuticals observations on file
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.103Calculation of yield1
- 21 CFR 211.22(d)Responsibilities of quality control unit1
- 21 CFR 211.84(b)Testing and approval or rejection of components, drug product containers, and closures1
The complete Niagara Pharmaceuticals file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Dundas, Canada
One Form 483 · 2022 · 4 observations
Latest: Form 483, Apr 25, 2022 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-04-25 | 483 Form 483 | Dundas, Canada | 4 | $99 |
Investigators on these documents
FEI number 3003093882 · most recent document Apr 25, 2022
About Niagara Pharmaceuticals, Inc
How many FDA Form 483s has Niagara Pharmaceuticals, Inc received?
FDA Intel has 1 Form 483 on file for Niagara Pharmaceuticals, Inc; the most recent is dated Apr 25, 2022.
When was Niagara Pharmaceuticals, Inc last inspected by FDA?
The most recent FDA inspection document on file for Niagara Pharmaceuticals, Inc is a Form 483 dated Apr 25, 2022, for the site in Dundas, Canada.
What did FDA cite at Niagara Pharmaceuticals, Inc?
The regulations cited most in the observations on file for Niagara Pharmaceuticals, Inc are 21 CFR 211.100(a) (Written procedures; deviations), 1 time; 21 CFR 211.103 (Calculation of yield), 1 time; 21 CFR 211.22(d) (Responsibilities of quality control unit), 1 time.