Novartis Manufacturing LLC
FDA inspection history in Indianapolis, Indiana, 2023 to 2025
- 2
- Form 483s
Every document, by year
- Form 483
2023: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2023–25Two Form 483s, at Indianapolis, Indiana.
- 2025The longest 483 on file: 3 observations over 3 pages at Indianapolis, Indiana.
Cited most
Across all Novartis Manufacturing observations on file
- 21 CFR 211.160General requirements1
- 21 CFR 211.188Batch production and control records1
- 21 CFR 211.194Laboratory records1
- 21 CFR 211.198Complaint files1
- 21 CFR 211.22Responsibilities of quality control unit1
The complete Novartis Manufacturing file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Indianapolis, Indiana
Two Form 483s · 2023 to 2025 · 5 observations
Latest: Form 483, Mar 4, 2025 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-03-04 | 483 Form 483 | Indianapolis, Indiana | 3 | $99 |
| 2023-10-27 | 483 Form 483 | Indianapolis, Indiana | 2 | $99 |
FEI number 3019881323 · most recent document Mar 4, 2025
About Novartis Manufacturing LLC
How many FDA Form 483s has Novartis Manufacturing LLC received?
FDA Intel has 2 Form 483s on file for Novartis Manufacturing LLC; the most recent is dated Mar 4, 2025.
When was Novartis Manufacturing LLC last inspected by FDA?
The most recent FDA inspection document on file for Novartis Manufacturing LLC is a Form 483 dated Mar 4, 2025, for the site in Indianapolis, Indiana.
What did FDA cite at Novartis Manufacturing LLC?
The regulations cited most in the observations on file for Novartis Manufacturing LLC are 21 CFR 211.160 (General requirements), 1 time; 21 CFR 211.188 (Batch production and control records), 1 time; 21 CFR 211.194 (Laboratory records), 1 time.