Form 483 · FEI 3014757826
Form 483 issued April 24, 2019 · Visp, Switzerland
- Inspection
- Apr 24, 2019
- Investigator
- Jamie L. Dion
- Observations
- 2
- Pages
- 2
- FEI number
- 3014757826
In short: On April 24, 2019, FDA issued a Form 483 with 2 observations to an FDA-inspected site in Visp, Switzerland (FEI 3014757826) after an inspection that ran Apr 24, 2019. The investigator was Jamie L. Dion. Most observations concern facilities & equipment and production.
At a glance
Facilities & equipment and production account for 2 of 2 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding the system…
- 02
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment…
This inspection in context
Jamie L. Dion
11 documents · 2013–2019
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Colorado.
The firmSite history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Jamie L. Dion is named on this Form 483, for the inspection of Apr 24, 2019. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Apr 24, 2019, and the Form 483 is dated April 24, 2019.
How do I get the full Form 483 for an FDA-inspected site?
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.