Halo Pharmaceutical Canada, Inc.
Form 483 issued September 28, 2023 · Mirabel, Canada
- Inspection
- Sep 25 – Sep 28, 2023
- Investigators
- David A. Oluwo· Kenneth H. Williams
- Observations
- 3
- Pages
- 2
- FEI number
- 3009856628
In short: On September 28, 2023, FDA issued a Form 483 with 3 observations to Halo Pharmaceutical Canada, Inc. in Mirabel, Quebec (FEI 3009856628) after an inspection that ran Sep 25 – Sep 28, 2023. The investigators were David A. Oluwo and Kenneth H. Williams. Most observations concern facilities & equipment and quality system.
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods…
- 03
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
This inspection in context
David A. Oluwo
27 documents · 2017–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Maryland.
The firmHalo Pharmaceutical Canada, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Halo Pharmaceutical Canada, Inc.?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected Halo Pharmaceutical Canada, Inc.?
David A. Oluwo and Kenneth H. Williams are named on this Form 483, for the inspection of Sep 25 – Sep 28, 2023. Each investigator has a profile showing what they cite most.
When was Halo Pharmaceutical Canada, Inc. inspected by FDA?
The inspection ran Sep 25 – Sep 28, 2023, and the Form 483 is dated September 28, 2023.
How do I get the full Form 483 for Halo Pharmaceutical Canada, 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.