Novartis Pharma Stein AG
Form 483 issued September 21, 2018 · Stein, Switzerland
- Inspection
- Sep 17 – Sep 21, 2018
- Observations
- 3
- Pages
- 3
- FEI number
- 3002653483
In short: On September 21, 2018, FDA issued a Form 483 with 3 observations to Novartis Pharma Stein AG in Stein, Switzerland (FEI 3002653483) after an inspection that ran Sep 17 – Sep 21, 2018. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Cleaning and sanitization for Fill Line (b) (4)…
- 03
Written procedures were not followed during manufacture on…
This inspection in context
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 most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
When was Novartis Pharma Stein AG inspected by FDA?
The inspection ran Sep 17 – Sep 21, 2018, and the Form 483 is dated September 21, 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.