Virbac Corporation
Form 483 issued November 25, 2019 · Bridgeton, Missouri
- Inspection
- Nov 13 – Nov 25, 2019
- Investigators
- Lisa L. Flores· Robert J. Ham
- Observations
- 2
- Pages
- 4
- FEI number
- 1944921
In short: On November 25, 2019, FDA issued a Form 483 with 2 observations to Virbac Corporation in Bridgeton, Missouri (FEI 1944921) after an inspection that ran Nov 13 – Nov 25, 2019. The investigators were Lisa L. Flores and Robert J. Ham. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.160 (1×) · 211.192 (1×)
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 specifications and test procedures…
- 02
Written records of investigations into the failure of a batch or any of its components to…
This inspection in context
Lisa L. Flores
20 documents · 2012–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmVirbac Corporation history
All 3 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 Virbac Corporation?
FDA listed 2 observations on this Form 483, mostly about laboratory controls and quality system. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Virbac Corporation?
Lisa L. Flores and Robert J. Ham are named on this Form 483, for the inspection of Nov 13 – Nov 25, 2019. Each investigator has a profile showing what they cite most.
When was Virbac Corporation inspected by FDA?
The inspection ran Nov 13 – Nov 25, 2019, and the Form 483 is dated November 25, 2019.
How do I get the full Form 483 for Virbac Corporation?
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.