Site records / Goa / FEI 3005124189

Indoco Remedies LimitedGoa, Goa

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

Inspections posted: 6
Last inspection: Feb 2023 · OAI
Warning letters to this FEI: 2
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%.

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Inspections

6 FDA inspections of this FEI, by end date; 6 with a posted classification.

28 Feb 2023OAI · Official Action IndicatedDrug Quality Assurance · 4 citations posted
21 Nov 2018VAI · Voluntary Action IndicatedDrug Quality Assurance · 2 citations posted
4 Sep 2016OAI · Official Action IndicatedDrug Quality Assurance · no citations posted
10 Jul 2015VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
30 Aug 2013OAI · Official Action IndicatedDrug Quality Assurance · no citations posted
23 Feb 2011VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted

Warning letters and compliance actions

16 Dec 2024Warning Letter · CDER SourceCGMP/Finished Pharmaceuticals/Adulterated
31 Mar 2017Warning Letter · CDER

Import alerts in force

No listing in force under this firm's name.

Form 483s released by FDA

4 Sep 2016Form 483 · 5 pages Source
4 Jun 2019Form 483 · 4 pages Source
26 Jul 2024Form 483 · 13 pages Source

Other registered sites of Indoco Remedies Limited

AnaCipher CLINICAL RESEARCH ORGANIZATIONHyderabad, Telangana
Indoco Remedies LimitedNavi Mumbai, Maharashtra
Indoco Remedies LimitedGoa, Goa
Indoco Remedies LimitedRaigad, Maharashtra

Registration

FEI: 3005124189
DUNS: 915851870
Registered as: INDOCO REMEDIES LIMITED
Registrant: Indoco Remedies Limited
Address: Goa Plant-II & III, L-32,33,34, Verna Industrial Area, Verna, Goa, Goa 403722, India (IND)
Operations: ANALYSIS, 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.