Site records / Madhya Pradesh / FEI 3007574780
Ipca Laboratories LimitedDhar, Madhya Pradesh
FDA-registered drug establishment in Dhar, Madhya Pradesh: analysis, label, manufacture, pack. Registration valid to 31 Dec 2026. Record as observed 27 Sep 2026.
- Inspections posted
- 4
- Last inspection
- Jun 2023 · VAI
- Warning letters to this FEI
- 1
- Import alerts at this address
- 0 of 1 under the name
- US border refusals, 2 years
- 0
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.
- 23 Jun 2023VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 17 Oct 2014OAI · Official Action IndicatedDrug Quality Assurance · no citations posted
- 26 Apr 2013VAI · Voluntary Action IndicatedDrug Quality Assurance · 3 citations posted
- 27 Jan 2012NAI · No 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 another site of this firm SourceDetention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.Published address: P.O. Sejavta , Ratlam, Madhya Pradesh INDIA
Form 483s released by FDA
- 23 Jun 2023Form 483 · 18 pages Source
Other registered sites of Ipca Laboratories
- Ipca Laboratories LimitedChhatrapati Sambhajinagar, Maharashtra
- Ipca Laboratories LimitedRatlam, Madhya Pradesh
- Ipca Laboratories LimitedSilvassa, Daman
- Ipca Laboratories LimitedPalghar, Maharashtra
Registration
- FEI
- 3007574780
- DUNS
- 677600550
- Registered as
- Ipca Laboratories Limited
- Registrant
- Ipca Laboratories Limited
- Address
- 1, Pharma Zone, SEZ, Indore, Pithampur, Dhar, 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.