Site records / Daman / FEI 3004561553

Sun Pharmaceutical Industries LimitedDadra, Daman

FDA-registered drug establishment in Dadra, Daman: analysis, manufacture. Registration valid to 31 Dec 2026. Record as observed 27 Sep 2026.

Inspections posted
5
Last inspection
Mar 2019 · VAI
Warning letters to this FEI
1
Import alerts at this address
0 of 4 under the name
US border refusals, 2 years
1
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. 29 Mar 2019VAI · Voluntary Action IndicatedDrug Quality Assurance · 11 citations posted
  2. 13 Apr 2017VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
  3. 30 Jan 2015VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
  4. 10 May 2013NAI · No Action IndicatedDrug Quality Assurance · no citations posted
  5. 17 Jun 2011NAI · No Action IndicatedDrug Quality Assurance · no citations posted

Warning letters and compliance actions

  1. 18 Jun 2024Warning Letter · CDER SourceCGMP/Finished Pharmaceuticals/Adulterated
  2. 16 Oct 2023Warning letter to Sun Pharmaceutical Industries Ltd. SourceCGMP/Active Pharmaceutical Ingredient (API)/Adulterated · issued to the firm name; FDA does not tie it to this FEI
  3. 8 Jun 2022Warning letter to New Sun Inc. SourceUnapproved New Drugs/Misbranded/Cannabidiol (CBD) Products · issued to the firm name; FDA does not tie it to this FEI
  4. 25 Aug 2010Warning letter to Sun Pharmaceutical Industries Inc SourceCGMP for Finished Pharmaceuticals/Adulterated · issued to the firm name; FDA does not tie it to this FEI
  5. 4 Mar 2010Warning letter to Sun Technologies, Inc. SourceTanning Facility/Federal Performance Standard for Sunlamp Products/Misbranded · issued to the firm name; FDA does not tie it to this FEI

Import alerts in force

Import-alert pages list a firm name and an address, never an FEI. Each listing under this firm's name is shown with the address FDA published and whether it is this site's.

  1. 7 Dec 2022Import alert 66-40 · Published address is another site of this firm SourcePublished address: Halol - Baroda Highway , Halol, Gujarat INDIA
  2. 12 Mar 2014Import alert 66-40 · Published address is not this site SourcePublished address: A Plot No 817 , Village Karkhadi , Padra, Gujarat INDIA
  3. 10 Sep 2009Import alert 66-40 · Published address is not this site SourcePublished address: Village Ganguwala , Tehsil-Paonta Sahib , Sirmaur, Himachal Pradesh INDIA
  4. 10 Sep 2009Import alert 66-40 · Published address is not this site SourcePublished address: 3 Industrial Area , Dewas, Madhya Pradesh INDIA

Form 483s released by FDA

  1. 13 Apr 2017Form 483 · 5 pages Source
  2. 15 Dec 2023Form 483 · 18 pages Source

Other registered sites of Sun Pharmaceutical Industries

Registration

FEI
3004561553
DUNS
650445203
Registered as
Sun Pharmaceutical Industries Limited
Registrant
Sun Pharmaceutical Industries Limited
Address
Survey No. 1012, Dadra, Union Territory of Dadra and Nagar Haveli and Daman and Diu 396193, India (IND)
Operations
ANALYSIS, 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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