Site records / Gujarat / FEI 3002809586

Sun Pharmaceutical Industries LimitedHalol, Gujarat

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

Inspections posted
12
Last inspection
Jun 2025 · OAI
Warning letters to this FEI
2
Import alerts at this address
1 of 4 under the name
US border refusals, 2 years
28
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

12 FDA inspections of this FEI, by end date; 12 with a posted classification.

  1. 13 Jun 2025OAI · Official Action IndicatedDrug Quality Assurance · 8 citations posted
  2. 9 May 2022OAI · Official Action IndicatedDrug Quality Assurance · 10 citations posted
  3. 13 Dec 2019OAI · Official Action IndicatedDrug Quality Assurance · 8 citations posted
  4. 11 Jun 2019VAI · Voluntary Action IndicatedCompliance: Devices, Drug Quality Assurance · no citations posted
  5. 6 Dec 2018NAI · No Action IndicatedDrug Quality Assurance · no citations posted
  6. 31 Aug 2018NAI · No Action IndicatedDrug Quality Assurance · no citations posted
  7. 23 Feb 2018VAI · Voluntary Action IndicatedDrug Quality Assurance · 3 citations posted
  8. 1 Dec 2016OAI · Official Action IndicatedDrug Quality Assurance · no citations posted
  9. 16 Sep 2014OAI · Official Action IndicatedDrug Quality Assurance · no citations posted
  10. 28 Sep 2012VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
  11. 13 Jun 2012VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
  12. 7 Apr 2011NAI · No Action IndicatedDrug Quality Assurance · no citations posted

Warning letters and compliance actions

  1. 15 Dec 2022Warning Letter · CDER
  2. 17 Dec 2015Warning Letter · CDER
  3. 18 Jun 2024Warning letter to Sun Pharmaceutical Industries Limited SourceCGMP/Finished Pharmaceuticals/Adulterated · issued to the firm name; FDA does not tie it to this FEI
  4. 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
  5. 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
  6. 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
  7. 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 this site 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. 1 Dec 2016Form 483 · 14 pages Source
  2. 23 Feb 2018Form 483 · 4 pages Source
  3. 31 Aug 2018Form 483 · 5 pages Source
  4. 11 Jun 2019Form 483 · 5 pages Source
  5. 13 Dec 2019Form 483 · 16 pages Source
  6. 9 May 2022Form 483 · 23 pages Source
  7. 13 Jun 2025Form 483 · 19 pages Source

Other registered sites of Sun Pharmaceutical Industries

Registration

FEI
3002809586
DUNS
725959238
Registered as
Sun Pharmaceutical Industries Limited
Registrant
Sun Pharmaceutical Industries Limited
Address
Halol-Baroda Highway, Halol, Gujarat 389350, 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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