Site records / Gujarat / FEI 3005183272

Elysium Pharmaceuticals LtdVadodara, Gujarat

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

Inspections posted
3
Last inspection
Jan 2023 · VAI
Warning letters to this FEI
0
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

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

  1. 16 Jan 2023VAI · Voluntary Action IndicatedDrug Quality Assurance · 5 citations posted
  2. 8 Sep 2017NAI · No Action IndicatedDrug Quality Assurance · no citations posted
  3. 26 Dec 2014VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted

Warning letters and compliance actions

No FDA compliance action recorded against this FEI or letter to its name.

Import alerts in force

No listing in force under this firm's name.

Registration

FEI
3005183272
DUNS
863182240
Registered as
ELYSIUM PHARMACEUTICALS LIMITED; Elysium Pharmaceuticals Ltd
Registrant
ELYSIUM PHARMACEUTICALS LTD
Address
253 to 256 and 258, Post: Dabhasa Taluka: Padra, Vadodara, Gujarat 391440, 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.

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