Site records / Goa / FEI 3004819820

Lupin LimitedSalcette, Goa

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

Inspections posted
9
Last inspection
Nov 2025 · VAI
Warning letters to this FEI
1
Import alerts at this address
0
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%.

PDF and data by email, usually within minutes, as of the day you buy. Card payment through Razorpay.

By buying you agree to the Terms and the refund policy: sales are final once delivered, except non-delivery.

Consultant plan · US$799 a month · five dossiers a month and watchlist alerts. Ask about the plan

Inspections

9 FDA inspections of this FEI, by end date; 9 with a posted classification.

  1. 21 Nov 2025VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
  2. 18 Sep 2021VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
  3. 8 Feb 2019OAI · Official Action IndicatedDrug Quality Assurance · no citations posted
  4. 11 Mar 2016VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
  5. 17 Jul 2015VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
  6. 17 May 2013NAI · No Action IndicatedDrug Quality Assurance · no citations posted
  7. 16 Sep 2011NAI · No Action IndicatedDrug Quality Assurance · no citations posted
  8. 12 Feb 2010VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
  9. 4 Mar 2009VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted

Warning letters and compliance actions

  1. 6 Nov 2017Warning Letter · CDER
  2. 27 Sep 2022Warning letter to Lupin Limited SourceCGMP/Active Pharmaceutical Ingredient (API)/Adulterated · issued to the firm name; FDA does not tie it to this FEI

Import alerts in force

No listing in force under this firm's name.

Form 483s released by FDA

  1. 17 Jul 2016Form 483 · 5 pages Source
  2. 7 Apr 2017Form 483 · 8 pages Source
  3. 8 Feb 2019Form 483 · 4 pages Source
  4. 21 Nov 2025Form 483 · 19 pages Source

Other registered sites of Lupin

Registration

FEI
3004819820
DUNS
677600414
Registered as
LUPIN LIMITED
Registrant
LUPIN LIMITED
Address
Plot No. 15-B, Phase 1-A, Verna Industrial Area, Verna, Salcette, Goa 403722, India (IND)
Operations
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.

COUNTERFOIL / CONTACT

Contact us.

How can we help?

Stored privately by Counterfoil. Your email is used only to respond to your enquiry.