Intervet International GMBH
Form 483 issued April 28, 2023 · Unterscheissheim, Germany
- Inspection
- Apr 20 – Apr 28, 2023
- Investigators
- Alan P. Kurtzberg· Kevin P. Regan
- Observations
- 2
- Pages
- 3
- FEI number
- 3003517550
In short: On April 28, 2023, FDA issued a Form 483 with 2 observations to Intervet International GMBH in Unterscheissheim, Germany (FEI 3003517550) after an inspection that ran Apr 20 – Apr 28, 2023. The investigators were Alan P. Kurtzberg and Kevin P. Regan. Most observations concern packaging & labeling and laboratory controls; the most-cited regulation is 21 CFR 211.122 (materials examination and usage criteria).
At a glance
Packaging & labeling and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.122 (1×) · 211.165(e) (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Access to the storage area for labels and labeling materials is not…
- 02
The accuracy, sensitivity, specificity and reproducibility of test methods have not…
This inspection in context
Alan P. Kurtzberg
24 documents · 2015–2023
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmIntervet International GMBH history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.122
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Intervet International GMBH?
FDA listed 2 observations on this Form 483, mostly about packaging & labeling and laboratory controls. The most-cited regulation is 21 CFR 211.122 (materials examination and usage criteria). The opening words of each observation are shown on this page.
Who inspected Intervet International GMBH?
Alan P. Kurtzberg and Kevin P. Regan are named on this Form 483, for the inspection of Apr 20 – Apr 28, 2023. Each investigator has a profile showing what they cite most.
When was Intervet International GMBH inspected by FDA?
The inspection ran Apr 20 – Apr 28, 2023, and the Form 483 is dated April 28, 2023.
How do I get the full Form 483 for Intervet International GMBH?
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.