Novartis Pharma Stein AG
Form 483 issued December 6, 2022 · Stein, Switzerland
- Inspection
- Nov 28 – Dec 6, 2022
- Investigator
- Edmund F. Mrak
- Observations
- 5
- Pages
- 4
- FEI number
- 3002653483
In short: On December 6, 2022, FDA issued a Form 483 with 5 observations to Novartis Pharma Stein AG in Stein, Switzerland (FEI 3002653483) after an inspection that ran Nov 28 – Dec 6, 2022. The investigator was Edmund F. Mrak. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
3 of 5 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 03
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 04
Written production and process control procedures are not followed in the execution of production…
This inspection in context
Edmund F. Mrak
30 documents · 2010–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Novartis Pharma Stein AG?
FDA listed 5 observations on this Form 483, mostly about production and facilities & equipment. 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 Novartis Pharma Stein AG?
Edmund F. Mrak is named on this Form 483, for the inspection of Nov 28 – Dec 6, 2022. Each investigator has a profile showing what they cite most.
When was Novartis Pharma Stein AG inspected by FDA?
The inspection ran Nov 28 – Dec 6, 2022, and the Form 483 is dated December 6, 2022.
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.