Sandoz Private Limited
FDA inspection history in Navi Mumbai, India, 2015 to 2024
- 1
- Form 483
- 1
- Close-out
- 1
- Warning letter
Every document, by year
- Form 483
- Close-out
- Warning letter
2015: one warning letter; 2017: one close-out letter; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–17One warning letter and one close-out letter, at Navi Mumbai, India.
- 2024One Form 483, at Navi Mumbai, India.
Cited most
Across all Sandoz Private Limited observations on file
- 21 CFR 211.113(a)Control of microbiological contamination1
The complete Sandoz Private Limited file.
All 3 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
Navi Mumbai, India
One Form 483, one close-out letter and one warning letter · 2015 to 2024 · 1 observation
Latest: Form 483, Jul 2, 2024 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-07-02 | 483 Form 483 | Navi Mumbai, India | 1 | $99 |
| 2017-06-08 | Close-out Close-out letter | Navi Mumbai, India | — | $99 |
| 2015-10-22 | Warning letter Warning letter | Navi Mumbai, India | — | $99 |
Investigators on these documents
FEI number 3004944629 · most recent document Jul 2, 2024
About Sandoz Private Limited
How many FDA Form 483s has Sandoz Private Limited received?
FDA Intel has 1 Form 483 on file for Sandoz Private Limited; the most recent is dated Jul 2, 2024.
When was Sandoz Private Limited last inspected by FDA?
The most recent FDA inspection document on file for Sandoz Private Limited is a Form 483 dated Jul 2, 2024, for the site in Navi Mumbai, India.
What did FDA cite at Sandoz Private Limited?
The regulations cited most in the observations on file for Sandoz Private Limited are 21 CFR 211.113(a) (Control of microbiological contamination), 1 time.
Has Sandoz Private Limited received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Sandoz Private Limited; the most recent is dated Oct 22, 2015.