Eurovet Animal Health B.V.
Form 483 issued October 25, 2022 · Bladel, Netherlands
- Inspection
- Oct 17 – Oct 25, 2022
- Investigator
- Justin A. Boyd
- Observations
- 11
- Pages
- 11
- FEI number
- 3003569803
In short: On October 25, 2022, FDA issued a Form 483 with 11 observations to Eurovet Animal Health B.V. in Bladel, Noord-Brabant (FEI 3003569803) after an inspection that ran Oct 17 – Oct 25, 2022. The investigator was Justin A. Boyd. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 7 of 11 observations.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established…
- 02
Observation 2: scanned text, readable in the full document.
- 03
(b) (4) processing areas are deficient regarding the system for monitoring environmental conditions. Establishment of the…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
This inspection in context
Justin A. Boyd
61 documents · 2010–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmEurovet Animal Health B.V. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Eurovet Animal Health B.V.?
FDA listed 11 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Eurovet Animal Health B.V.?
Justin A. Boyd is named on this Form 483, for the inspection of Oct 17 – Oct 25, 2022. Each investigator has a profile showing what they cite most.
When was Eurovet Animal Health B.V. inspected by FDA?
The inspection ran Oct 17 – Oct 25, 2022, and the Form 483 is dated October 25, 2022.
How do I get the full Form 483 for Eurovet Animal Health B.V.?
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.