Site records / Gujarat / FEI 3005029956

Torrent Pharmaceuticals LimitedIndrad, Gujarat

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

Inspections posted: 6
Last inspection: Jun 2024 · 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%.

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Inspections

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

12 Jun 2024VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
28 Sep 2022OAI · Official Action IndicatedDrug Quality Assurance · 3 citations posted
28 Apr 2017VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
20 May 2016VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
31 Mar 2015VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
26 Jul 2013VAI · Voluntary Action IndicatedDrug Quality Assurance · 1 citation posted

Warning letters and compliance actions

8 Oct 2019Warning Letter · CDER

Import alerts in force

No listing in force under this firm's name.

Form 483s released by FDA

28 Apr 2017Form 483 · 5 pages Source
16 Apr 2019Form 483 · 17 pages Source
12 Jun 2024Form 483 · 7 pages Source

Other registered sites of Torrent Pharmaceuticals

Torrent Pharmaceuticals LimitedVisakhapatnam, Andhra Pradesh
Torrent Pharmaceuticals LimitedPithampur, Madhya Pradesh
Torrent Pharmaceuticals LimitedBharuch, Gujarat
Torrent Pharmaceuticals LimitedGandhinagar, Gujarat

Registration

FEI: 3005029956
DUNS: 916488547
Registered as: Torrent Pharmaceuticals Limited
Registrant: Torrent Pharma, Inc.
Address: Ahmedabad-Mehsana Highway, Indrad, Taluka-Kadi, Dist. Mehsana, Indrad, Gujarat 382721, India (IND)
Operations: ANALYSIS, API MANUFACTURE, 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.