Lonza AG
Form 483 issued March 28, 2023 · Visp, Switzerland
- Investigators
- Santos Comers· Vishal Patel
- 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). The investigators were Santos Comers and Vishal Patel. 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
1, EAR-2579, 30-Jul-2019, 2. EAR-2581, 29-Jul-2019 3. EAR-2585, 31-Jul-2019, - EAR-2688, 14-Oct-2019. 5. EAR-3296…
This inspection in context
Santos Comers
1 document · 2023
Cites 211.194 (laboratory records) 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 211.194
See how FDA wrote the same problem up elsewhere.
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.
Who inspected Lonza AG?
Santos Comers and Vishal Patel are named on this Form 483. Each investigator has a profile showing what they cite most.
When was Lonza AG inspected by FDA?
This 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.