Novartis Pharmaceuticals Corporation
Form 483 issued December 9, 2022 · Morris Plains, New Jersey
- Inspection
- Nov 28 – Dec 9, 2022
- Investigators
- Thai D. Truong· Unnee Ranjan
- Observations
- 6
- Pages
- 7
- FEI number
- 3010353512
In short: On December 9, 2022, FDA issued a Form 483 with 6 observations to Novartis Pharmaceuticals Corporation in Morris Plains, New Jersey (FEI 3010353512) after an inspection that ran Nov 28 – Dec 9, 2022. The investigators were Thai D. Truong and Unnee Ranjan. Most observations concern facilities & equipment and materials.
At a glance
Facilities & equipment and materials account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…
- 02
Failure to reject any lot of drug product containers and closures that did not meet the…
- 03
There are no written procedures for production and process controls designed to assure that the drug…
- 04
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
This inspection in context
Thai D. Truong
12 documents · 2022–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Massachusetts.
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 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Novartis Pharmaceuticals Corporation?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, materials and production. The opening words of each observation are shown on this page.
Who inspected Novartis Pharmaceuticals Corporation?
Thai D. Truong and Unnee Ranjan are named on this Form 483, for the inspection of Nov 28 – Dec 9, 2022. Each investigator has a profile showing what they cite most.
When was Novartis Pharmaceuticals Corporation inspected by FDA?
The inspection ran Nov 28 – Dec 9, 2022, and the Form 483 is dated December 9, 2022.
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.