Halo Pharmaceutical Canada, Inc.
FDA inspection history in Mirabel, Canada, 2014 to 2023
- 2
- Form 483s
Every document, by year
- Form 483
2014: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2014One Form 483, at Mirabel, Canada.
- 2014The longest 483 on file: 5 observations over 3 pages at Mirabel, Canada.
- 2023One Form 483, at Mirabel, Canada.
Cited most
Across all Halo Pharmaceutical Canada observations on file
- 21 CFR 211.192Production record review2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.134Drug product inspection1
- 21 CFR 211.160General requirements1
- 21 CFR 211.63Equipment design, size, and location1
The complete Halo Pharmaceutical Canada file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Mirabel, Canada
Two Form 483s · 2014 to 2023 · 8 observations
Latest: Form 483, Sep 28, 2023 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-09-28 | 483 Form 483 | Mirabel, Canada | 3 | $99 |
| 2014-11-14 | 483 Form 483 | Mirabel, Canada | 5 | $99 |
Investigators on these documents
Daniel J. Roberts (1)David A. Oluwo (1)Kenneth H. Williams (1)
FEI number 3009856628 · most recent document Sep 28, 2023
About Halo Pharmaceutical Canada, Inc.
How many FDA Form 483s has Halo Pharmaceutical Canada, Inc. received?
FDA Intel has 2 Form 483s on file for Halo Pharmaceutical Canada, Inc.; the most recent is dated Sep 28, 2023.
When was Halo Pharmaceutical Canada, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Halo Pharmaceutical Canada, Inc. is a Form 483 dated Sep 28, 2023, for the site in Mirabel, Canada.
What did FDA cite at Halo Pharmaceutical Canada, Inc.?
The regulations cited most in the observations on file for Halo Pharmaceutical Canada, Inc. are 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.134 (Drug product inspection), 1 time.