Vetio Animal Health ULC
Form 483 issued August 18, 2023 · Saint-Laurent, Canada
- Inspection
- Aug 14 – Aug 18, 2023
- Investigator
- Bryan L. McGuckin
- Observations
- 5
- Pages
- 6
- FEI number
- 3005813881
In short: On August 18, 2023, FDA issued a Form 483 with 5 observations to Vetio Animal Health ULC in Saint-Laurent, Quebec (FEI 3005813881) after an inspection that ran Aug 14 – Aug 18, 2023. The investigator was Bryan L. McGuckin. Most observations concern facilities & equipment and quality system.
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in taster…
- 02
Written records of investigations into unexplained discrepancies do not always include…
- 03
The calibration of instruments and gauges is not done at suitable intervals with provisions for remedial…
- 04
The preparation of your master production and control records was not followed in accordance…
This inspection in context
Bryan L. McGuckin
30 documents · 2017–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Illinois.
The firmVetio Animal Health ULC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Vetio Animal Health ULC?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Vetio Animal Health ULC?
Bryan L. McGuckin is named on this Form 483, for the inspection of Aug 14 – Aug 18, 2023. Each investigator has a profile showing what they cite most.
When was Vetio Animal Health ULC inspected by FDA?
The inspection ran Aug 14 – Aug 18, 2023, and the Form 483 is dated August 18, 2023.
How do I get the full Form 483 for Vetio Animal Health ULC?
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.