Site records / Karnataka / FEI 3013140488

R.L.Fine Chem Private LimitedBengaluru, Karnataka

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

Inspections posted
1
Last inspection
Apr 2023 · VAI
Warning letters to this FEI
0
Import alerts at this address
0 of 3 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

1 FDA inspection of this FEI, by end date; 1 with a posted classification.

  1. 14 Apr 2023VAI · 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.

  1. 17 Mar 2015Import alert 66-41 · Published address is not this site SourceDetention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.Published address: 3, SHANTA INDL EST , OFF: W E HIGHWAY , KASHIMIRA, THANE - MAHARAHSTRA INDIA
  2. 29 May 2014Import alert 66-41 · Published address is not this site SourceDetention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.Published address: D - 27 Sector Ii , Noida, Uttar Pradesh INDIA
  3. 30 Sep 2009Import alert 66-66 · Published address is not this site SourcePublished address: 89 Princess Street , Bombay, MS INDIA

Registration

FEI
3013140488
DUNS
871410164
Registered as
R.L.Fine Chem Private Limited
Registrant
R.L.Fine Chem Private Limited
Address
Plot No. IP-27-29, KIADB Industrial Area, 1st Phase, Kudumalakunte Village, Chikkabalapur District, Gowribidanoor, Bengaluru, Karnataka 561208, 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.

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