Site records / Maharashtra / FEI 3009565091
Gopaldas Visram and Company LimitedNavi Mumbai, Maharashtra
FDA-registered drug establishment in Navi Mumbai, Maharashtra: manufacture. Registration valid to 31 Dec 2026. Record as observed 27 Sep 2026.
- Inspections posted
- 3
- Last inspection
- Jan 2025 · VAI
- Warning letters to this FEI
- 1
- Import alerts at this address
- 2
- US border refusals, 2 years
- 2
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
3 FDA inspections of this FEI, by end date; 3 with a posted classification.
- 24 Jan 2025VAI · Voluntary Action IndicatedDrug Quality Assurance · 5 citations posted
- 15 Nov 2019VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 1 Dec 2017VAI · Voluntary Action IndicatedDrug Quality Assurance · 6 citations posted
Warning letters and compliance actions
- 2 Jun 2026Warning Letter · CDER SourceCGMP/OTC 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.
- 9 Feb 2021Import alert 66-41 · Published address is this site SourceDetention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.Published address: A - 590/591 Ttc Ind Area , Navi , Navi Mumbai, Maharashtra INDIA
- 16 Aug 2019Import alert 66-41 · Published address is this site SourceDetention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.Published address: A/327, TTC Industrial Area, MIDC Mahape , Navi Mumbai, Maharashtra INDIA
Registration
- FEI
- 3009565091
- DUNS
- 858030888
- Registered as
- GOPALDAS VISRAM AND COMPANY LIMITED
- Registrant
- GOPALDAS VISRAM AND COMPANY LIMITED
- Address
- A/327, TTC Industrial Area, MIDC Mahape, Navi Mumbai, Maharashtra 400710, India (IND)
- Operations
- 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.