Site records / Uttarakhand / FEI 3006895982

Jubilant Generics LimitedRoorkee, Uttarakhand

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

Inspections posted: 8
Last inspection: Feb 2024 · VAI
Warning letters to this FEI: 1
Import alerts at this address: 0
US border refusals, 2 years: 0

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

8 FDA inspections of this FEI, by end date; 8 with a posted classification.

2 Feb 2024VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
1 Aug 2022OAI · Official Action IndicatedDrug Quality Assurance · 6 citations posted
12 Mar 2021OAI · Official Action IndicatedDrug Quality Assurance · no citations posted
6 Nov 2019OAI · Official Action IndicatedDrug Quality Assurance · 6 citations posted
23 Mar 2017NAI · No Action IndicatedDrug Quality Assurance · no citations posted
8 Apr 2016VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
13 Mar 2015VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
1 Mar 2013VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted

Warning letters and compliance actions

6 Mar 2019Warning Letter · CDER

Import alerts in force

No listing in force under this firm's name.

Form 483s released by FDA

12 Mar 2021Form 483 · 16 pages Source
2 Feb 2024Form 483 · 6 pages Source

Registration

FEI: 3006895982
DUNS: 650369221
Registered as: Jubilant Generics Limited
Registrant: JUBILANT GENERICS LIMITED
Address: Village Sikandarpur Bhainswal, Roorkee- Dehradun Highway, Bhagwanpur, Distt. Haridwar, Roorkee, Uttarakhand 247661, 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.