Novartis Manufacturing LLC
Form 483 issued March 4, 2025 · Indianapolis, Indiana
- Observations
- 3
- Pages
- 3
- FEI number
- 3019881323
In short: On March 4, 2025, FDA issued a Form 483 with 3 observations to Novartis Manufacturing LLC in Indianapolis, Indiana (FEI 3019881323). Most observations concern materials and production.
At a glance
Materials and production account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
- 02
Batch production and control records do not include the in-process control results for each batch…
- 03
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Questions about this 483
What did FDA find at Novartis Manufacturing LLC?
FDA listed 3 observations on this Form 483, mostly about materials, production and quality system. The opening words of each observation are shown on this page.
When was Novartis Manufacturing LLC inspected by FDA?
This Form 483 is dated March 4, 2025.
How do I get the full Form 483 for Novartis Manufacturing LLC?
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.