Megafine Pharma (P) Limited
FDA inspection history in Nashik, India, 2016 to 2023
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2016: one warning letter; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016One warning letter, at Nashik, India.
- 2023One Form 483, at Nashik, India.
Cited most
Across all Megafine Pharma (P) Limited observations on file
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.130Packaging and labeling operations1
- 21 CFR 211.160General requirements1
- 21 CFR 211.188Batch production and control records1
- 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
Nashik, India
One Form 483 and one warning letter · 2016 to 2023 · 7 observations
Latest: Form 483, Jan 24, 2023 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-01-24 | 483 Form 483 | Nashik, India | 7 | $99 |
| 2016-05-19 | Warning letter Warning letter | Nashik, India | — | $99 |
FEI number 3005694111 · most recent document Jan 24, 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 Jan 24, 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 Jan 24, 2023, for the site in Nashik, 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 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.130 (Packaging and labeling operations), 1 time; 21 CFR 211.160 (General requirements), 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 May 19, 2016.