Site records / Maharashtra / FEI 3005694111

Megafine Pharma (P) LimitedNashik, Maharashtra

FDA-registered drug establishment in Nashik, Maharashtra: api manufacture. Registration valid to 31 Dec 2026. Record as observed 27 Sep 2026.

Inspections posted
5
Last inspection
Jan 2023 · VAI
Warning letters to this FEI
1
Import alerts at this address
0
US border refusals, 2 years
0
The site dossier

This site, graded.
Every fact sourced.

  • A grade from A to E on a registered ten-factor rubric, with the fact behind every factor
  • Every posted FDA citation, sorted into failure categories and set against Indian drug inspections
  • Warning-letter violations, numbered and labelled
  • Import-alert history rebuilt from the archive, each listing checked against this address
  • Border refusals by product, and the company's other sites, each graded
  • A hash of every source read, so the PDF can be checked against the record

On 2022–26 inspections the rubric never saw, grade E sites were classified OAI 26.5% of the time and grade A sites 4.0%.

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Inspections

5 FDA inspections of this FEI, by end date; 5 with a posted classification.

  1. 24 Jan 2023VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
  2. 6 Mar 2020OAI · Official Action IndicatedDrug Quality Assurance · no citations posted
  3. 12 May 2018OAI · Official Action IndicatedDrug Quality Assurance · no citations posted
  4. 15 May 2015OAI · Official Action IndicatedDrug Quality Assurance, Monitoring of Marketed Animal Drugs, Feed, and Devices, Pre-Approval Eval. of Animal Drugs and Food Additives · no citations posted
  5. 2 Jun 2011NAI · No Action IndicatedDrug Quality Assurance, Pre-Approval Eval. of Animal Drugs and Food Additives · no citations posted

Warning letters and compliance actions

  1. 19 May 2016Warning Letter · CDER SourceCGMP/Active Pharmaceutical Ingredient (API)/Adulterated

Import alerts in force

No listing in force under this firm's name.

Other registered sites of Megafine Pharma (P) Limited

Registration

FEI
3005694111
DUNS
925627080
Registered as
Megafine Pharma (P) Limited
Registrant
Megafine Pharma (P) Limited
Address
Plot No 1 to 5, 31-35 & 48-51, 26 & K/201 Lakhmapur, Tal. Dindori, Nashik, Maharashtra 422202, India (IND)
Operations
API MANUFACTURE
Registration expires
31 Dec 2026

Sources: FDA drug establishment registrations, FDA Data Dashboard inspections and compliance actions, import-alert pages, warning letters, import refusals and the FDA reading room, as held in Counterfoil's point-in-time corpus. No matched action does not establish compliance, and FDA registration is not FDA approval. Sources and coverage.

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