SERUM INSTITUTE OF INDIA PRIVATE LIMITED
FDA inspection history in Pune, 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 Pune, India.
Cited most
Across all SERUM INSTITUTE OF INDIA PRIVATE LIMITED observations on file
- 21 CFR 211.192Production record review2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.194Laboratory records1
- 21 CFR 211.67Equipment cleaning and maintenance1
The complete SERUM INSTITUTE OF INDIA PRIVATE LIMITED file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Pune, India
One Form 483 · 2024 · 5 observations
Latest: Form 483, Jul 2, 2024 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-07-02 | 483 Form 483 | Pune, India | 5 | $99 |
Investigators on these documents
FEI number 3020223359 · most recent document Jul 2, 2024
About SERUM INSTITUTE OF INDIA PRIVATE LIMITED
How many FDA Form 483s has SERUM INSTITUTE OF INDIA PRIVATE LIMITED received?
FDA Intel has 1 Form 483 on file for SERUM INSTITUTE OF INDIA PRIVATE LIMITED; the most recent is dated Jul 2, 2024.
When was SERUM INSTITUTE OF INDIA PRIVATE LIMITED last inspected by FDA?
The most recent FDA inspection document on file for SERUM INSTITUTE OF INDIA PRIVATE LIMITED is a Form 483 dated Jul 2, 2024, for the site in Pune, India.
What did FDA cite at SERUM INSTITUTE OF INDIA PRIVATE LIMITED?
The regulations cited most in the observations on file for SERUM INSTITUTE OF INDIA PRIVATE LIMITED are 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.113 (Control of microbiological contamination), 1 time.