Lonza AG
Form 483 issued December 15, 2017 · Visp, Switzerland
- Inspection
- Dec 11 – Dec 15, 2017
- Investigators
- Frances Namuswe· Maria Jose Lopez Barragan· Tiara N. Brown-Crosen
- Observations
- 1
- Pages
- 1
- FEI number
- 3002930340
In short: On December 15, 2017, FDA issued a Form 483 with 1 observation to Lonza AG in Visp, Switzerland (FEI 3002930340) after an inspection that ran Dec 11 – Dec 15, 2017. The investigators were Frances Namuswe, Maria Jose Lopez Barragan and Tiara N. Brown-Crosen. Most observations concern production; the most-cited regulation is 21 CFR 211.111 (time limitations on production).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.111 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Master production instructions do not include time limits and controlled conditions for completion of individual…
This inspection in context
Frances Namuswe
2 documents · 2017–2018
Cites 211.84 (testing and approval or rejection of components, drug product containers, and closures) more than any other section. Most of their documents are for sites in California.
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 211.111
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 211.111 (time limitations on production). The opening words of each observation are shown on this page.
Who inspected Lonza AG?
Frances Namuswe, Maria Jose Lopez Barragan and Tiara N. Brown-Crosen are named on this Form 483, for the inspection of Dec 11 – Dec 15, 2017. Each investigator has a profile showing what they cite most.
When was Lonza AG inspected by FDA?
The inspection ran Dec 11 – Dec 15, 2017, and the Form 483 is dated December 15, 2017.
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.