Site records / Maharashtra / FEI 3004455093

Sharon Bio-Medicine LimitedRaigad, Maharashtra

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

Inspections posted: 3
Last inspection: Apr 2025 · VAI
Warning letters to this FEI: 0
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

3 FDA inspections of this FEI, by end date; 3 with a posted classification.

18 Apr 2025VAI · Voluntary Action IndicatedMonitoring of Marketed Animal Drugs, Feed, and Devices · no citations posted
22 Feb 2019VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
7 Jul 2015VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted

Warning letters and compliance actions

No FDA compliance action recorded against this FEI or letter to its name.

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.

13 Jul 2016Import alert 66-76 · Published address is not this site SourcePublished address: Khasra No 1027/28/30/37, Selaqui Industrial Area , Central Hope Town , Dehradun, Uttarakhand INDIA

Registration

FEI: 3004455093
DUNS: 675472749
Registered as: Sharon Bio-Medicine Limited
Registrant: Sharon BioMedicine Limited
Address: Plot No. L-6, MIDC, Taloja,, Raigad, Maharashtra 410208, 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.