Site records / Gujarat / FEI 3002984011

Zydus Lifesciences LimitedAhmedabad, Gujarat

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

Inspections posted
10
Last inspection
Aug 2022 · VAI
Warning letters to this FEI
3
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

10 FDA inspections of this FEI, by end date; 10 with a posted classification.

  1. 5 Aug 2022VAI · Voluntary Action IndicatedDrug Quality Assurance · 4 citations posted
  2. 3 May 2019OAI · Official Action IndicatedDrug Quality Assurance · 14 citations posted
  3. 22 Mar 2019NAI · No Action IndicatedBioresearch Monitoring · no citations posted
  4. 9 Feb 2018NAI · No Action IndicatedDrug Quality Assurance · no citations posted
  5. 16 Feb 2017NAI · No Action IndicatedDrug Quality Assurance · no citations posted
  6. 5 Sep 2014OAI · Official Action IndicatedDrug Quality Assurance · 4 citations posted
  7. 19 Aug 2013VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
  8. 23 Feb 2012VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
  9. 3 Feb 2011OAI · Official Action IndicatedDrug Quality Assurance · no citations posted
  10. 6 Feb 2009NAI · No Action IndicatedDrug Quality Assurance · no citations posted

Warning letters and compliance actions

  1. 29 Oct 2019Warning Letter · CDER
  2. 23 Dec 2015Warning Letter · CDER
  3. 21 Jun 2011Warning Letter · CDER
  4. 2 Jun 2026Warning letter to Zydus Lifesciences Limited SourceRequest for Records/CGMP/Finished Pharmaceuticals/Adulterated · issued to the firm name; FDA does not tie it to this FEI
  5. 29 Aug 2024Warning letter to Zydus Lifesciences Limited SourceCGMP/Finished Pharmaceuticals/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. 3 May 2019Form 483 · 23 pages Source

Other registered sites of Zydus Lifesciences

Registration

FEI
3002984011
DUNS
918596198
Registered as
Zydus Lifesciences Limited
Registrant
Zydus Lifesciences Limited
Address
Survey No. 417, 419 and 420, Sarkhej Bavla N. H. No. 8A Village-Moraiya, Taluka-Sanand Ahmedabad, Ahmedabad, Gujarat 382210, India (IND)
Operations
ANALYSIS, MANUFACTURE
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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