Siegfried Evionnaz SA
Form 483 issued March 31, 2023 · Evionnaz, Switzerland
- Inspection
- Mar 27 – Mar 31, 2023
- Observations
- 3
- Pages
- 6
- FEI number
- 3002807824
In short: On March 31, 2023, FDA issued a Form 483 with 3 observations to Siegfried Evionnaz SA in Evionnaz, Switzerland (FEI 3002807824) after an inspection that ran Mar 27 – Mar 31, 2023. Most observations concern facilities & equipment and laboratory controls.
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Production equipment used to manufacture Intermediates and APIs, is not of appropriate design and…
- 02
Stability characteristics of APIs is not monitored…
- 03
Buildings used to manufacture intermediates and APIs are not…
This inspection in context
Questions about this 483
What did FDA find at Siegfried Evionnaz SA?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
When was Siegfried Evionnaz SA inspected by FDA?
The inspection ran Mar 27 – Mar 31, 2023, and the Form 483 is dated March 31, 2023.
How do I get the full Form 483 for Siegfried Evionnaz SA?
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.