Novartis Pharmaceuticals Corporation
Form 483 issued August 8, 2024 · Morris Plains, New Jersey
- Inspection
- Jul 30 – Aug 8, 2024
- Investigator
- Laurel A. Beer
- Observations
- 4
- Pages
- 6
- FEI number
- 3010353512
In short: On August 8, 2024, FDA issued a Form 483 with 4 observations to Novartis Pharmaceuticals Corporation in Morris Plains, New Jersey (FEI 3010353512) after an inspection that ran Jul 30 – Aug 8, 2024. The investigator was Laurel A. Beer. Most observations concern production and laboratory controls.
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 02
EMPLOYEE{S) SIGNATURE Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, sampling…
- 03
The responsibilities and procedures applicable to the quality control unit…
- 04
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Laurel A. Beer
14 documents · 2021–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in North Carolina.
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 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Novartis Pharmaceuticals Corporation?
FDA listed 4 observations on this Form 483, mostly about production, laboratory controls and quality system. The opening words of each observation are shown on this page.
Who inspected Novartis Pharmaceuticals Corporation?
Laurel A. Beer is named on this Form 483, for the inspection of Jul 30 – Aug 8, 2024. Each investigator has a profile showing what they cite most.
When was Novartis Pharmaceuticals Corporation inspected by FDA?
The inspection ran Jul 30 – Aug 8, 2024, and the Form 483 is dated August 8, 2024.
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.