SYNGENE INTERNATIONAL LIMITED
FDA inspection history in Bengaluru, India, 2025
- 1
- Form 483
Every document, by year
- Form 483
2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2025One Form 483, at Bengaluru, India.
Cited most
Across all SYNGENE INTERNATIONAL LIMITED observations on file
- 21 CFR 211.42Design and construction features2
- 21 CFR 211.188Batch production and control records1
- 21 CFR 211.192Production record review1
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures1
The complete SYNGENE INTERNATIONAL LIMITED file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Bengaluru, India
One Form 483 · 2025 · 5 observations
Latest: Form 483, Feb 20, 2025 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-02-20 | 483 Form 483 | Bengaluru, India | 5 | $99 |
FEI number 3003600340 · most recent document Feb 20, 2025
About SYNGENE INTERNATIONAL LIMITED
How many FDA Form 483s has SYNGENE INTERNATIONAL LIMITED received?
FDA Intel has 1 Form 483 on file for SYNGENE INTERNATIONAL LIMITED; the most recent is dated Feb 20, 2025.
When was SYNGENE INTERNATIONAL LIMITED last inspected by FDA?
The most recent FDA inspection document on file for SYNGENE INTERNATIONAL LIMITED is a Form 483 dated Feb 20, 2025, for the site in Bengaluru, India.
What did FDA cite at SYNGENE INTERNATIONAL LIMITED?
The regulations cited most in the observations on file for SYNGENE INTERNATIONAL LIMITED are 21 CFR 211.42 (Design and construction features), 2 times; 21 CFR 211.188 (Batch production and control records), 1 time; 21 CFR 211.192 (Production record review), 1 time.