Brassica Pharma Pvt Ltd.
FDA inspection history in Thane, 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 Thane, India.
Cited most
Across all Brassica Pharma Pvt observations on file
- 21 CFR 211.113(b)Control of microbiological contamination2
- 21 CFR 211.42(c)(10)Design and construction features2
- 21 CFR 211.100(b)Written procedures; deviations1
- 21 CFR 211.160(b)General requirements1
- 21 CFR 211.188Batch production and control records1
The complete Brassica Pharma Pvt 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
Thane, India
One warning letter and one Form 483 · 2024 · 10 observations
Latest: Warning letter, Jul 11, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-07-11 | Warning letter Warning letter | Thane, India | — | $99 |
| 2024-01-19 | 483 Form 483 | Thane, India | 10 | $99 |
Investigators on these documents
FEI number 3014129013 · most recent document Jul 11, 2024
About Brassica Pharma Pvt Ltd.
How many FDA Form 483s has Brassica Pharma Pvt Ltd. received?
FDA Intel has 1 Form 483 on file for Brassica Pharma Pvt Ltd.; the most recent is dated Jan 19, 2024.
When was Brassica Pharma Pvt Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Brassica Pharma Pvt Ltd. is a Form 483 dated Jan 19, 2024, for the site in Thane, India.
What did FDA cite at Brassica Pharma Pvt Ltd.?
The regulations cited most in the observations on file for Brassica Pharma Pvt Ltd. are 21 CFR 211.113(b) (Control of microbiological contamination), 2 times; 21 CFR 211.42(c)(10) (Design and construction features), 2 times; 21 CFR 211.100(b) (Written procedures; deviations), 1 time.
Has Brassica Pharma Pvt Ltd. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Brassica Pharma Pvt Ltd.; the most recent is dated Jul 11, 2024.