Novartis Pharmaceuticals Corporation
Form 483 issued April 7, 2017 · Morris Plains, New Jersey
- Inspection
- Apr 3 – Apr 7, 2017
- Investigators
- Ashley Burns· Denise Gavin· Joan Johnson
- Observations
- 2
- Pages
- 2
- FEI number
- 3010353512
In short: On April 7, 2017, FDA issued a Form 483 with 2 observations to Novartis Pharmaceuticals Corporation in Morris Plains, New Jersey (FEI 3010353512) after an inspection that ran Apr 3 – Apr 7, 2017. The investigators were Ashley Burns, Denise Gavin, Joan Johnson, Randa Meihem and Xinobin Lu. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.100 (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Process validation for CTL-019 manufacturing (b) (4) was incomplete at the…
- 02
Observation 2: scanned text, readable in the full document.
This inspection in context
Ashley Burns
1 document · 2017
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in New Jersey.
The firmNovartis Pharmaceuticals Corporation history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Novartis Pharmaceuticals Corporation?
FDA listed 2 observations on this Form 483, mostly about production and quality system. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Novartis Pharmaceuticals Corporation?
Ashley Burns, Denise Gavin, Joan Johnson, Randa Meihem and Xinobin Lu are named on this Form 483, for the inspection of Apr 3 – Apr 7, 2017. Each investigator has a profile showing what they cite most.
When was Novartis Pharmaceuticals Corporation inspected by FDA?
The inspection ran Apr 3 – Apr 7, 2017, and the Form 483 is dated April 7, 2017.
How do I get the full Form 483 for Novartis Pharmaceuticals Corporation?
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.