Site records / Telangana / FEI 3004021263

Aurobindo Pharma LimitedSangareddy, Telangana

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

Inspections posted: 5
Last inspection: Sep 2023 · 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

5 FDA inspections of this FEI, by end date; 5 with a posted classification.

29 Sep 2023VAI · Voluntary Action IndicatedDrug Quality Assurance · 1 citation posted
1 Sep 2017VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
9 Dec 2014NAI · No Action IndicatedDrug Quality Assurance · no citations posted
21 Sep 2012VAI · Voluntary Action IndicatedDrug Quality Assurance · 7 citations posted
22 Dec 2010OAI · Official Action IndicatedDrug Quality Assurance · no citations posted

Warning letters and compliance actions

20 May 2011Warning Letter · CDER SourceCGMP/Finished Pharmaceuticals/Adulterated
12 Jan 2022Warning letter to Aurobindo Pharmaceutical Limited SourceCGMP/Active Pharmaceutical Ingredient (API)/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 Sep 2017Form 483 · 2 pages Source

Other registered sites of Aurobindo Pharma

Apl Healthcare LimitedTirupati, Andhra Pradesh
Aurobindo Pharma LimitedMedchal, Telangana
Aurobindo Pharma LimitedMedchal, Telangana
Aurobindo Pharma LimitedMahabubnagar, Telangana

Registration

FEI: 3004021263
DUNS: 918917639
Registered as: Aurobindo Pharma Limited
Registrant: Aurobindo Pharma Limited
Address: Unit-VI, Sy. No.329/39 & 329/47, Chitkul Village, Patancheru Mandal, Sanga Reddy District, Sangareddy, Telangana 502307, 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.