Form 483 · FEI 3014757826
Form 483 issued February 28, 2024 · Visp, Switzerland
- Observations
- 9
- Pages
- 7
- FEI number
- 3014757826
In short: On February 28, 2024, FDA issued a Form 483 with 9 observations to an FDA-inspected site in Visp, Switzerland (FEI 3014757826). Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and quality system account for 6 of 9 observations.
Most cited: 21 CFR 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 02
Your firm failed to…
- 03
Your examination and testing of samples did not assure that the drug product and in-process…
- 04
Aseptic processing areas are inadequate regarding the system…
This inspection in context
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 9 observations on this Form 483, mostly about facilities & equipment, quality system and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
When was an FDA-inspected site inspected by FDA?
This Form 483 is dated February 28, 2024.
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.