Lonza AG
Form 483 issued March 28, 2023 · Visp, Switzerland
- Inspection
- Mar 20 – Mar 28, 2023
- Observations
- 1
- Pages
- 2
- FEI number
- 3002930340
In short: On March 28, 2023, FDA issued a Form 483 with 1 observation to Lonza AG in Visp, Switzerland (FEI 3002930340) after an inspection that ran Mar 20 – Mar 28, 2023. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.194 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
A) Laboratory records do not include complete data derived from all tests, examinations and assay necessary…
This inspection in context
Questions about this 483
What did FDA find at Lonza AG?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
When was Lonza AG inspected by FDA?
The inspection ran Mar 20 – Mar 28, 2023, and the Form 483 is dated March 28, 2023.
How do I get the full Form 483 for Lonza AG?
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.