Lonza AG
Form 483 issued October 28, 2025 · Visp, Switzerland
- Inspection
- Oct 20 – Oct 28, 2025
- Investigators
- Alexander Sohr· Lei Zhang· Ralph M. Bernstein
- Observations
- 4
- Pages
- 3
- FEI number
- 3002930340
In short: On October 28, 2025, FDA issued a Form 483 with 4 observations to Lonza AG in Visp, Switzerland (FEI 3002930340) after an inspection that ran Oct 20 – Oct 28, 2025. The investigators were Alexander Sohr, Lei Zhang, Ralph M. Bernstein and Reyes Candau-Chacon. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and laboratory controls account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The information provided by the firm does not…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Process Parameters (PPs) are not adequately controlled within established ranges…
- 04
Critical material used to manufacture® (4) is not tracked, maintained, or…
This inspection in context
Alexander Sohr
1 document · 2025
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Switzerland.
The firmLonza AG history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.166
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Lonza AG?
FDA listed 4 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Lonza AG?
Alexander Sohr, Lei Zhang, Ralph M. Bernstein and Reyes Candau-Chacon are named on this Form 483, for the inspection of Oct 20 – Oct 28, 2025. Each investigator has a profile showing what they cite most.
When was Lonza AG inspected by FDA?
The inspection ran Oct 20 – Oct 28, 2025, and the Form 483 is dated October 28, 2025.
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.