Site records / India / FEI 3001413302

Dabur India LimitedSilvassa

FDA-registered drug establishment in Silvassa: label, manufacture, pack. Registration valid to 31 Dec 2026. Record as observed 27 Sep 2026.

Inspections posted
3
Last inspection
Jan 2026 · OAI
Warning letters to this FEI
1
Import alerts at this address
2 of 14 under the name
US border refusals, 2 years
94
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

3 FDA inspections of this FEI, by end date; 3 with a posted classification.

  1. 16 Jan 2026OAI · Official Action IndicatedDrug Quality Assurance · 7 citations posted
  2. 6 Dec 2019VAI · Voluntary Action IndicatedDrug Quality Assurance · 2 citations posted
  3. 14 Oct 2016VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted

Warning letters and compliance actions

  1. 24 Jul 2026Warning Letter · CDER SourceCGMP/Finished Pharmaceuticals/Adulterated

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. 5 Jun 2026Import alert 66-40 · Published address is this site SourcePublished address: 225 - 4 - 1 Saily Village , Survey No , Dadra And Nagar Haveli, Dadra and Nagar Haveli And Dam INDIA
  2. 14 Oct 2012Import alert 66-41 · Published address is this site SourceDetention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.Published address: 225 - 4 - 1 Saily Village , Survey No , Dadra And Nagar Haveli, Dadra and Nagar Haveli And Dam INDIA
  3. 26 Aug 2025Import alert 66-41 · Published address is not this site SourceDetention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.Published address: 45 46 47 Plot No 44 , And 97; Smart Industrial Park , Pithampur, Madhya Pradesh INDIA
  4. 1 Nov 2021Import alert 66-41 · Published address is not this site SourceDetention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.Published address: Lane no. 3, phase-2 , SIDCO Industrial Complex, Bari Brahmana , Jammu, Jammu and Kashmir INDIA
  5. 1 Nov 2021Import alert 66-41 · Published address is not this site SourceDetention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.Published address: SP -C 162 , Matsya Industrial Area , Alwar, Rajasthan INDIA
  6. 28 Feb 2020Import alert 66-41 · Published address is another site of this firm SourceDetention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.Published address: Honey Unit, Tehsil Baddi , Manakpur , Solan, Himachal Pradesh INDIA
  7. 4 Feb 2020Import alert 66-41 · Published address is not this site SourceDetention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.Published address: Sanitpur , Garaimari, Assam INDIA
  8. 4 Feb 2020Import alert 66-41 · Published address is not this site SourceDetention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.Published address: Integrated Industrial Estate, Plot No 4, Sec-2, Pant Nagar, Distt. Udham Singh Nagar , Udham Singh Nagar, Uttaranchal INDIA
  9. 13 Sep 2019Import alert 66-41 · Published address is not this site SourceDetention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.Published address: P.O. Daburgram , Bihar, INDIA
  10. 10 Jan 2017Import alert 66-41 · Published address is not this site SourceDetention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.Published address: 8/3 Asaf Ali Road , New Delhi, Delhi INDIA
  11. 14 Oct 2015Import alert 66-41 · Published address is not this site SourceDetention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.Published address: 109 Hpsidc Industrial Area , Baddi, Himachal Pradesh INDIA
  12. 29 May 2014Import alert 66-41 · Published address is not this site SourceDetention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.Published address: 86 A, Kheda Industrial Area, Pithampur , Dhar, Madhya Pradesh INDIA
  13. 13 Jun 2013Import alert 66-41 · Published address is another site of this firm SourceDetention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.Published address: Village Billanwali Lavana, Baddi , Solan, Himachal Pradesh INDIA
  14. 22 Nov 2010Import alert 66-41 · Published address is not this site SourceDetention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.Published address: 60 Maiku Majra , Malku Majra Road; Nalagarth Road , Baddi, Himachal Pradesh INDIA

Form 483s released by FDA

  1. 16 Jan 2026Form 483 · 9 pages Source
  2. 16 Jan 2026Form 483 · 9 pages Source

Registration

FEI
3001413302
DUNS
650599231
Registered as
Dabur India Limited
Registrant
Dabur India Limited
Address
Survey No 225- 4 -1, Saily Village, Silvassa, 396240, India (IND)
Operations
LABEL, MANUFACTURE, PACK
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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