Novartis Pharma AG
Form 483 issued August 30, 2022 · Basel, Switzerland
- Inspection
- Aug 26 – Aug 30, 2022
- Investigator
- Yasamin Ameri
- Observations
- 3
- Pages
- 2
- FEI number
- 3002807772
In short: On August 30, 2022, FDA issued a Form 483 with 3 observations to Novartis Pharma AG in Basel, Switzerland (FEI 3002807772) after an inspection that ran Aug 26 – Aug 30, 2022. The investigator was Yasamin Ameri. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.68 (2×) · 211.170 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Computerized systems should have sufficient controls to prevent unauthorized access…
- 02
Equipment used in storage and processing of drug substances…
- 03
There should be enough reserve sample to cover…
This inspection in context
Yasamin Ameri
20 documents · 2015–2022
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in India.
The firmNovartis Pharma AG history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Novartis Pharma AG?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Novartis Pharma AG?
Yasamin Ameri is named on this Form 483, for the inspection of Aug 26 – Aug 30, 2022. Each investigator has a profile showing what they cite most.
When was Novartis Pharma AG inspected by FDA?
The inspection ran Aug 26 – Aug 30, 2022, and the Form 483 is dated August 30, 2022.
How do I get the full Form 483 for Novartis Pharma 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.