Site records / Gujarat / FEI 3009336980

Goran Pharma Private LimitedSihor, Gujarat

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

Inspections posted: 3
Last inspection: Feb 2025 · VAI
Warning letters to this FEI: 1
Import alerts at this address: 0
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.

28 Feb 2025VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
12 Dec 2019NAI · No Action IndicatedDrug Quality Assurance · no citations posted
15 Nov 2017OAI · Official Action IndicatedDrug Quality Assurance · 17 citations posted

Warning letters and compliance actions

24 Apr 2018Warning Letter · CDER

Import alerts in force

No listing in force under this firm's name.

Registration

FEI: 3009336980
DUNS: 862174088
Registered as: GORAN PHARMA PRIVATE LIMITED
Registrant: GORAN PHARMA PRIVATE LIMITED
Address: GIDC - I, Bhavnagar Rajkot Road, Dist. Bhavnagar, Sihor, Gujarat, India 364240, 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.