Megafine Pharma (P) Limited
FDA inspection history in Vapi, India, 2017 to 2023
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2017: one warning letter; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017One warning letter, at Vapi, India.
- 2023One Form 483, at Vapi, India.
Cited most
Across all Megafine Pharma (P) Limited observations on file
- 21 CFR 211.160General requirements1
- 21 CFR 211.192Production record review1
The complete Megafine Pharma (P) 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
Vapi, India
One Form 483 and one warning letter · 2017 to 2023 · 2 observations
Latest: Form 483, May 12, 2023 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-05-12 | 483 Form 483 | Vapi, India | 2 | $99 |
| 2017-02-24 | Warning letter Warning letter | Vapi, India | — | $99 |
Investigators on these documents
FEI number 3006688078 · most recent document May 12, 2023
About Megafine Pharma (P) Limited
How many FDA Form 483s has Megafine Pharma (P) Limited received?
FDA Intel has 1 Form 483 on file for Megafine Pharma (P) Limited; the most recent is dated May 12, 2023.
When was Megafine Pharma (P) Limited last inspected by FDA?
The most recent FDA inspection document on file for Megafine Pharma (P) Limited is a Form 483 dated May 12, 2023, for the site in Vapi, India.
What did FDA cite at Megafine Pharma (P) Limited?
The regulations cited most in the observations on file for Megafine Pharma (P) Limited are 21 CFR 211.160 (General requirements), 1 time; 21 CFR 211.192 (Production record review), 1 time.
Has Megafine Pharma (P) Limited received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Megafine Pharma (P) Limited; the most recent is dated Feb 24, 2017.