Site records / Madhya Pradesh / FEI 3008581988

Cipla LimitedIndore, Madhya Pradesh

FDA-registered drug establishment in Indore, Madhya Pradesh: analysis, label, manufacture, pack. Registration valid to 31 Dec 2026. Record as observed 27 Sep 2026.

Inspections posted
6
Last inspection
Feb 2023 · OAI
Warning letters to this FEI
1
Import alerts at this address
0 of 3 under the name
US border refusals, 2 years
2
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%.

PDF and data by email, usually within minutes, as of the day you buy. Card payment through Razorpay.

By buying you agree to the Terms and the refund policy: sales are final once delivered, except non-delivery.

Consultant plan · US$799 a month · five dossiers a month and watchlist alerts. Ask about the plan

Inspections

6 FDA inspections of this FEI, by end date; 6 with a posted classification.

  1. 17 Feb 2023OAI · Official Action IndicatedDrug Quality Assurance · no citations posted
  2. 17 May 2019NAI · No Action IndicatedDrug Quality Assurance · no citations posted
  3. 13 Apr 2018VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
  4. 7 Aug 2015VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
  5. 1 Mar 2013VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
  6. 2 Nov 2012NAI · No Action IndicatedDrug Quality Assurance · no citations posted

Warning letters and compliance actions

  1. 17 Nov 2023Warning Letter · CDER SourceCGMP/Finished Pharmaceuticals/Adulterated

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. 13 Apr 2018Form 483 · 5 pages Source
  2. 1 Jul 2022Form 483 · 2 pages Source
  3. 17 Feb 2023Form 483 · 23 pages Source

Other registered sites of Cipla

Registration

FEI
3008581988
DUNS
918596409
Registered as
CIPLA LIMITED
Registrant
CIPLA LIMITED
Address
Plot No. 9 &10 Indore Special Economic Zone, Phase II - Pithampur, District Dhar, Indore, Madhya Pradesh 454775, India (IND)
Operations
ANALYSIS, LABEL, 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.

COUNTERFOIL / CONTACT

Contact us.

How can we help?

Stored privately by Counterfoil. Your email is used only to respond to your enquiry.