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
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.
- 21 Oct 2023VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 13 Jun 2023VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 18 Jul 2014OAI · Official Action IndicatedDrug Quality Assurance, Monitoring of Marketed Animal Drugs, Feed, and Devices · no citations posted
- 19 Sep 2011VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
Warning letters and compliance actions
- 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.
- 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
- Ipca Laboratories LimitedChhatrapati Sambhajinagar, Maharashtra
- Ipca Laboratories LimitedSilvassa, Daman
- Ipca Laboratories LimitedPalghar, Maharashtra
- Ipca Laboratories LimitedDhar, Madhya Pradesh
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.