Site records / Telangana / FEI 3004021229
Aurobindo Pharma LimitedMedchal, Telangana
FDA-registered drug establishment in Medchal, Telangana: analysis, manufacture. Registration valid to 31 Dec 2026. Record as observed 27 Sep 2026.
- Inspections posted
- 12
- Last inspection
- Jul 2023 · VAI
- Warning letters to this FEI
- 0
- Import alerts at this address
- 0
- US border refusals, 2 years
- 0
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
12 FDA inspections of this FEI, by end date; 12 with a posted classification.
- 21 Jul 2023VAI · Voluntary Action IndicatedDrug Quality Assurance · 3 citations posted
- 5 Jul 2019VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 24 May 2019VAI · Voluntary Action IndicatedDrug Quality Assurance · 10 citations posted
- 10 Aug 2018VAI · Voluntary Action IndicatedBioresearch Monitoring · 2 citations posted
- 18 Apr 2017VAI · Voluntary Action IndicatedDrug Quality Assurance · 6 citations posted
- 29 Jan 2016NAI · No Action IndicatedDrug Quality Assurance · no citations posted
- 26 Jun 2015VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 2 Mar 2012NAI · No Action IndicatedDrug Quality Assurance · no citations posted
- 8 Sep 2011VAI · Voluntary Action IndicatedBioresearch Monitoring, Drug Quality Assurance · 1 citation posted
- 24 Sep 2010OAI · Official Action IndicatedDrug Quality Assurance · no citations posted
- 22 Oct 2009NAI · No Action IndicatedDrug Quality Assurance · no citations posted
- 30 Jan 2009NAI · No Action IndicatedDrug Quality Assurance · no citations posted
Warning letters and compliance actions
- 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
- 20 May 2011Warning letter to Aurobindo Pharma 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
Other registered sites of Aurobindo Pharma
- Apl Healthcare LimitedTirupati, Andhra Pradesh
- Aurobindo Pharma LimitedSangareddy, Telangana
- Aurobindo Pharma LimitedMedchal, Telangana
- Aurobindo Pharma LimitedMahabubnagar, Telangana
Registration
- FEI
- 3004021229
- DUNS
- 918917642
- Registered as
- Aurobindo Pharma Limited
- Registrant
- Aurobindo Pharma Limited
- Address
- Unit-III, Sy. No.313 & 314, Bachupally, Bachupally Mandal, Medchal-Malkajgiri District, Medchal, Telangana 500090, 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.