Synergene Active Ingredients Private Limited
FDA inspection history in Anakapalli, India, 2024
- 1
- Form 483
Every document, by year
- Form 483
2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2024One Form 483, at Anakapalli, India.
Cited most
Across all Synergene Active Ingredients Private Limited observations on file
- 21 CFR 211.188Batch production and control records1
- 21 CFR 211.192Production record review1
- 21 CFR 211.67Equipment cleaning and maintenance1
The complete Synergene Active Ingredients Private Limited file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Anakapalli, India
One Form 483 · 2024 · 3 observations
Latest: Form 483, Feb 17, 2024 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-02-17 | 483 Form 483 | Anakapalli, India | 3 | $99 |
Investigators on these documents
FEI number 3010634351 · most recent document Feb 17, 2024
About Synergene Active Ingredients Private Limited
How many FDA Form 483s has Synergene Active Ingredients Private Limited received?
FDA Intel has 1 Form 483 on file for Synergene Active Ingredients Private Limited; the most recent is dated Feb 17, 2024.
When was Synergene Active Ingredients Private Limited last inspected by FDA?
The most recent FDA inspection document on file for Synergene Active Ingredients Private Limited is a Form 483 dated Feb 17, 2024, for the site in Anakapalli, India.
What did FDA cite at Synergene Active Ingredients Private Limited?
The regulations cited most in the observations on file for Synergene Active Ingredients Private Limited are 21 CFR 211.188 (Batch production and control records), 1 time; 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.67 (Equipment cleaning and maintenance), 1 time.