Halo Pharmaceutical Canada, Inc.
Form 483 issued November 14, 2014 · Mirabel, Canada
- Inspection
- Nov 10 – Nov 14, 2014
- Investigator
- Daniel J. Roberts
- Observations
- 5
- Pages
- 3
- FEI number
- 3009856628
In short: On November 14, 2014, FDA issued a Form 483 with 5 observations to Halo Pharmaceutical Canada, Inc. in Mirabel, Quebec (FEI 3009856628) after an inspection that ran Nov 10 – Nov 14, 2014. The investigator was Daniel J. Roberts. Most observations concern laboratory controls and quality system.
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 02
Written records of investigations into the failure of a batch or any of its components to…
- 03
Samples of representative units were not visually examined for correct labeling at the…
- 04
Changes to written procedures are not reviewed and approved by…
This inspection in context
Daniel J. Roberts
14 documents · 2011–2017
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
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 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Halo Pharmaceutical Canada, Inc.?
FDA listed 5 observations on this Form 483, mostly about laboratory controls, quality system and packaging & labeling. The opening words of each observation are shown on this page.
Who inspected Halo Pharmaceutical Canada, Inc.?
Daniel J. Roberts is named on this Form 483, for the inspection of Nov 10 – Nov 14, 2014. Each investigator has a profile showing what they cite most.
When was Halo Pharmaceutical Canada, Inc. inspected by FDA?
The inspection ran Nov 10 – Nov 14, 2014, and the Form 483 is dated November 14, 2014.
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.