Site records / Madhya Pradesh / FEI 3002807297

Ipca Laboratories LimitedRatlam, Madhya Pradesh

FDA-registered drug establishment in Ratlam, Madhya Pradesh: api manufacture. Registration valid to 31 Dec 2026. Record as observed 27 Sep 2026.

Inspections posted
4
Last inspection
Oct 2023 · VAI
Warning letters to this FEI
1
Import alerts at this address
1
US border refusals, 2 years
1
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

4 FDA inspections of this FEI, by end date; 4 with a posted classification.

  1. 21 Oct 2023VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
  2. 13 Jun 2023VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
  3. 18 Jul 2014OAI · Official Action IndicatedDrug Quality Assurance, Monitoring of Marketed Animal Drugs, Feed, and Devices · no citations posted
  4. 19 Sep 2011VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted

Warning letters and compliance actions

  1. 29 Jan 2016Warning Letter · CDER SourceCGMP/APIs and 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. 30 Sep 2009Import alert 66-41 · Published address is this site SourceDetention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.Published address: P.O. Sejavta , Ratlam, Madhya Pradesh INDIA

Other registered sites of Ipca Laboratories

Registration

FEI
3002807297
DUNS
862179827
Registered as
Ipca Laboratories Limited
Registrant
Ipca Laboratories Limited
Address
P.O. Sejavta, Ratlam, Madhya Pradesh 457001, India (IND)
Operations
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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