Novartis Pharmaceuticals Corporation
Form 483 issued August 21, 2019 · Morris Plains, New Jersey
- Inspection
- Aug 13 – Aug 21, 2019
- Investigators
- Jacqueline M. Diaz Albert· Kimberly L. Schultz· Susan M. Jackson
- Observations
- 4
- Pages
- 7
- FEI number
- 3010353512
In short: On August 21, 2019, FDA issued a Form 483 with 4 observations to Novartis Pharmaceuticals Corporation in Morris Plains, New Jersey (FEI 3010353512) after an inspection that ran Aug 13 – Aug 21, 2019. The investigators were Jacqueline M. Diaz Albert, Kimberly L. Schultz and Susan M. Jackson. Most observations concern production and quality system.
At a glance
Production and quality system account for 4 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 03
Investigations of a failure of a batch or any of its components to meet any of…
- 04
Written procedures are not established for evaluations done at least annually and including provisions for a…
This inspection in context
Jacqueline M. Diaz Albert
1 document · 2019
Cites 211.110(a) (sampling and testing of in-process materials and drug products) 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 211.110(a)
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 and quality system. The opening words of each observation are shown on this page.
Who inspected Novartis Pharmaceuticals Corporation?
Jacqueline M. Diaz Albert, Kimberly L. Schultz and Susan M. Jackson are named on this Form 483, for the inspection of Aug 13 – Aug 21, 2019. Each investigator has a profile showing what they cite most.
When was Novartis Pharmaceuticals Corporation inspected by FDA?
The inspection ran Aug 13 – Aug 21, 2019, and the Form 483 is dated August 21, 2019.
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.