Site records / Daman / FEI 3005977675

Ipca Laboratories LimitedSilvassa, Daman

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

Inspections posted
5
Last inspection
Apr 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
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

5 FDA inspections of this FEI, by end date; 5 with a posted classification.

  1. 26 Apr 2023VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
  2. 23 Aug 2019OAI · Official Action IndicatedDrug Quality Assurance · 3 citations posted
  3. 19 Dec 2014OAI · Official Action IndicatedDrug Quality Assurance · no citations posted
  4. 31 Jul 2012VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
  5. 28 May 2010VAI · Voluntary Action IndicatedDrug Quality Assurance · 9 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 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

  1. 23 Aug 2019Form 483 · 10 pages Source
  2. 26 Apr 2023Form 483 · 7 pages Source

Other registered sites of Ipca Laboratories

Registration

FEI
3005977675
DUNS
918917303
Registered as
Ipca Laboratories Limited
Registrant
Ipca Laboratories Limited
Address
Plot No. 65, 99 and 126, Danudyog Industrial Estate, Piparia, Silvassa, U.T. of Dadra and Nagar Haveli and Daman and Diu 396230, 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.

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