Novartis Pharma Stein AG
Form 483 issued December 4, 2018 · Stein, Switzerland
- Inspection
- Nov 26 – Dec 4, 2018
- Investigator
- Travis S. Bradley
- Observations
- 3
- Pages
- 3
- FEI number
- 3002653483
In short: On December 4, 2018, FDA issued a Form 483 with 3 observations to Novartis Pharma Stein AG in Stein, Switzerland (FEI 3002653483) after an inspection that ran Nov 26 – Dec 4, 2018. The investigator was Travis S. Bradley. Most observations concern facilities & equipment and production.
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Written production and process control procedures are not documented at…
This inspection in context
Travis S. Bradley
12 documents · 2018–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Switzerland.
The firmNovartis Pharma Stein AG history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42(c)(10)(iv)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Novartis Pharma Stein AG?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Novartis Pharma Stein AG?
Travis S. Bradley is named on this Form 483, for the inspection of Nov 26 – Dec 4, 2018. Each investigator has a profile showing what they cite most.
When was Novartis Pharma Stein AG inspected by FDA?
The inspection ran Nov 26 – Dec 4, 2018, and the Form 483 is dated December 4, 2018.
How do I get the full Form 483 for Novartis Pharma Stein 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.