Site records / Gujarat / FEI 3007621329

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
9
Last inspection
Jun 2025 · 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

9 FDA inspections of this FEI, by end date; 9 with a posted classification.

  1. 17 Jun 2025VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
  2. 27 Mar 2024OAI · Official Action IndicatedDrug Quality Assurance · 4 citations posted
  3. 4 Feb 2020NAI · No Action IndicatedDrug Quality Assurance · no citations posted
  4. 26 Mar 2019NAI · No Action IndicatedDrug Quality Assurance · no citations posted
  5. 21 Mar 2019VAI · Voluntary Action IndicatedBioresearch Monitoring · no citations posted
  6. 5 Jun 2018NAI · No Action IndicatedDrug Quality Assurance · no citations posted
  7. 17 Apr 2015VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
  8. 31 Jan 2014VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
  9. 4 Oct 2012VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted

Warning letters and compliance actions

  1. 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
  2. 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. 27 Mar 2024Form 483 · 6 pages Source

Other registered sites of Zydus Lifesciences

Registration

FEI
3007621329
DUNS
650348852
Registered as
Zydus Lifesciences Limited
Registrant
Zydus Lifesciences Limited
Address
Plot No. 1A, PHARMEZ Special Economic Zone, Sarkhej - Bavla N. H. No. 8A, Matoda, Tal : Sanand, Ahmedabad, Gujarat 382213, 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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