Site records / Telangana / FEI 3005447965

Dr. Reddy's Laboratories LimitedNalgonda, Telangana

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

Inspections posted
7
Last inspection
May 2025 · 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

7 FDA inspections of this FEI, by end date; 7 with a posted classification.

  1. 24 May 2025VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
  2. 5 Mar 2020VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
  3. 28 Jan 2019VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
  4. 21 Feb 2017VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
  5. 31 Jan 2015OAI · Official Action IndicatedDrug Quality Assurance · no citations posted
  6. 1 May 2012VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
  7. 6 Feb 2009VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted

Warning letters and compliance actions

  1. 5 Nov 2015Warning Letter · CDER

Import alerts in force

No listing in force under this firm's name.

Form 483s released by FDA

  1. 21 Feb 2017Form 483 · 3 pages Source
  2. 5 Mar 2020Form 483 · 2 pages Source

Other registered sites of Dr. Reddy's Laboratories

Registration

FEI
3005447965
DUNS
650443471
Registered as
DR. REDDY'S LABORATORIES LIMITED
Registrant
Dr. Reddy's Laboratories Limited
Address
Peddadevulapally, Tripuraram Mandal, Nalgonda, Telangana 508 207, India (IND)
Operations
ANALYSIS, API 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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