Sumar Biotech LLP
FDA inspection history in Mehsana, 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 Mehsana, India.
Cited most
Across all Sumar Biotech LLP observations on file
- 21 CFR 211.160General requirements1
- 21 CFR 211.165Testing and release for distribution1
- 21 CFR 211.166Stability testing1
- 21 CFR 211.186Master production and control records1
- 21 CFR 211.22Responsibilities of quality control unit1
The complete Sumar Biotech LLP file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Mehsana, India
One Form 483 · 2024 · 5 observations
Latest: Form 483, Jan 12, 2024 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-01-12 | 483 Form 483 | Mehsana, India | 5 | $99 |
Investigators on these documents
FEI number 3028729506 · most recent document Jan 12, 2024
About Sumar Biotech LLP
How many FDA Form 483s has Sumar Biotech LLP received?
FDA Intel has 1 Form 483 on file for Sumar Biotech LLP; the most recent is dated Jan 12, 2024.
When was Sumar Biotech LLP last inspected by FDA?
The most recent FDA inspection document on file for Sumar Biotech LLP is a Form 483 dated Jan 12, 2024, for the site in Mehsana, India.
What did FDA cite at Sumar Biotech LLP?
The regulations cited most in the observations on file for Sumar Biotech LLP are 21 CFR 211.160 (General requirements), 1 time; 21 CFR 211.165 (Testing and release for distribution), 1 time; 21 CFR 211.166 (Stability testing), 1 time.