Lonza AG
Form 483 issued February 3, 2022 · Stein AG, Switzerland
- Inspection
- Jan 27 – Feb 3, 2022
- Investigator
- Michael R. Shanks
- Observations
- 1
- Pages
- 1
- FEI number
- 3016502617
In short: On February 3, 2022, FDA issued a Form 483 with 1 observation to Lonza AG in Stein AG, Switzerland (FEI 3016502617) after an inspection that ran Jan 27 – Feb 3, 2022. The investigator was Michael R. Shanks. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment not suitable for…
This inspection in context
Michael R. Shanks
27 documents · 2017–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
The firmLonza AG history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113
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 production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Lonza AG?
Michael R. Shanks is named on this Form 483, for the inspection of Jan 27 – Feb 3, 2022. Each investigator has a profile showing what they cite most.
When was Lonza AG inspected by FDA?
The inspection ran Jan 27 – Feb 3, 2022, and the Form 483 is dated February 3, 2022.
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.