Bhargava Phytolab Private Limited
FDA inspection history in Bhiwadi, India, 2024
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2024: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2024One warning letter and one Form 483, at Bhiwadi, India.
Cited most
Across all Bhargava Phytolab Private Limited observations on file
- 21 CFR 211.192Production record review2
- 21 CFR 211.84(d)(1)Testing and approval or rejection of components, drug product containers, and closures2
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.188(b)(3)Batch production and control records1
- 21 CFR 211.22(d)Responsibilities of quality control unit1
The complete Bhargava Phytolab Private Limited file.
All 2 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
Bhiwadi, India
One warning letter and one Form 483 · 2024 · 9 observations
Latest: Warning letter, Dec 18, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-12-18 | Warning letter Warning letter | Bhiwadi, India | — | $99 |
| 2024-07-26 | 483 Form 483 | Bhiwadi, India | 9 | $99 |
Investigators on these documents
FEI number 3012809762 · most recent document Dec 18, 2024
About Bhargava Phytolab Private Limited
How many FDA Form 483s has Bhargava Phytolab Private Limited received?
FDA Intel has 1 Form 483 on file for Bhargava Phytolab Private Limited; the most recent is dated Jul 26, 2024.
When was Bhargava Phytolab Private Limited last inspected by FDA?
The most recent FDA inspection document on file for Bhargava Phytolab Private Limited is a Form 483 dated Jul 26, 2024, for the site in Bhiwadi, India.
What did FDA cite at Bhargava Phytolab Private Limited?
The regulations cited most in the observations on file for Bhargava Phytolab Private Limited are 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.84(d)(1) (Testing and approval or rejection of components, drug product containers, and closures), 2 times; 21 CFR 211.100(a) (Written procedures; deviations), 1 time.
Has Bhargava Phytolab Private Limited received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Bhargava Phytolab Private Limited; the most recent is dated Dec 18, 2024.