Novartis Manufacturing LLC
Form 483 issued October 27, 2023 · Indianapolis, Indiana
- Observations
- 2
- Pages
- 3
- FEI number
- 3019881323
In short: On October 27, 2023, FDA issued a Form 483 with 2 observations to Novartis Manufacturing LLC in Indianapolis, Indiana (FEI 3019881323). Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
2 of 2 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.194 (1×) · 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory records do not include complete records of any testing and standardization…
- 02
Observation 2: scanned text, readable in the full document.
This inspection in context
Questions about this 483
What did FDA find at Novartis Manufacturing LLC?
FDA listed 2 observations on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
When was Novartis Manufacturing LLC inspected by FDA?
This Form 483 is dated October 27, 2023.
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.