Site records / Karnataka / FEI 3002806691

Cipla LimitedBengaluru, Karnataka

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

Inspections posted
7
Last inspection
Nov 2024 · VAI
Warning letters to this FEI
0
Import alerts at this address
0 of 3 under the name
US border refusals, 2 years
3
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. 13 Nov 2024VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
  2. 31 Jan 2020VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
  3. 19 Jul 2019VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
  4. 5 Apr 2017VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
  5. 25 Jul 2014VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
  6. 28 Jun 2012VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
  7. 9 Apr 2009VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted

Warning letters and compliance actions

  1. 17 Nov 2023Warning letter to Cipla Limited SourceCGMP/Finished Pharmaceuticals/Adulterated · issued to the firm name; FDA does not tie it to this FEI

Import alerts in force

Import-alert pages list a firm name and an address, never an FEI. Each listing under this firm's name is shown with the address FDA published and whether it is this site's.

  1. 14 Mar 2017Import alert 66-41 · Published address is not this site SourceDetention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.Published address: Khasra No. 509/1-2 & 520 , Vii-Bhagwanpur , Bhagwanpur, Uttaranchal INDIA
  2. 9 Oct 2013Import alert 66-66 · Published address is another site of this firm SourcePublished address: Patalganga Industrial Area , Plot No A-2, A-33, A-37/2/2, A-42 , Raigad, Maharashtra INDIA
  3. 18 Oct 2010Import alert 66-66 · Published address is another site of this firm SourcePublished address: Plots D-7, D-22, D-27 , M.I.D.C. Industrial Area, Taluka-Daund , Kurkumbh Village, Dist. Pune, Maharashtra INDIA

Form 483s released by FDA

  1. 19 Jul 2019Form 483 · 6 pages Source

Other registered sites of Cipla

Registration

FEI
3002806691
DUNS
915154892
Registered as
CIPLA LIMITED
Registrant
CIPLA LIMITED
Address
Virgonagar, Old Madras Road, Bengaluru, Karnataka 560049, India (IND)
Operations
ANALYSIS, API 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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