Site records / Karnataka / FEI 3003981475

Biocon Biologics LimitedBengaluru, Karnataka

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

Inspections posted: 11
Last inspection: Jul 2024 · VAI
Warning letters to this FEI: 0
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%.

PDF and data by email, usually within minutes, as of the day you buy. Card payment through Razorpay.

By buying you agree to the Terms and the refund policy: sales are final once delivered, except non-delivery.

Consultant plan · US$799 a month · five dossiers a month and watchlist alerts. Ask about the plan

Inspections

11 FDA inspections of this FEI, by end date; 11 with a posted classification.

26 Jul 2024VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
26 Aug 2022OAI · Official Action IndicatedDrug Quality Assurance · no citations posted
30 Aug 2019VAI · Voluntary Action IndicatedDrug Quality Assurance · 4 citations posted
1 May 2018VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
3 Jun 2017VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
29 Oct 2015VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
16 Jun 2015VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
19 Jun 2012NAI · No Action IndicatedDrug Quality Assurance · no citations posted
13 Jun 2012NAI · No Action IndicatedDrug Quality Assurance · no citations posted
29 Jan 2009VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
29 Jan 2009VAI · 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

No listing in force under this firm's name.

Form 483s released by FDA

7 Apr 2017Form 483 · 6 pages Source
2 Jun 2017Form 483 · 8 pages Source
1 May 2018Form 483 · 4 pages Source
15 Feb 2019Form 483 · 5 pages Source
26 Aug 2022Form 483 · 18 pages Source
26 Jul 2024Form 483 · 14 pages Source

Other registered sites of Biocon

Biocon Pharma LimitedBengaluru, Karnataka
Biocon Biologics LimitedBengaluru, Karnataka
Biocon Biosphere LimitedAnakapalli, Andhra Pradesh
Biocon LimitedBengaluru, Karnataka
Biocon LimitedSangareddy, Telangana
Biocon LimitedAnakapalli, Andhra Pradesh
Biocon LimitedBengaluru, Karnataka

Registration

FEI: 3003981475
DUNS: 650501997
Registered as: Biocon Biologics Limited
Registrant: Biocon Biologics Limited
Address: Block No, B1,B2, B3, B5, Q13 of Q1 and W20 & Unit S18,1st Floor,Block B4, SEZ, Plot No.2,3,4&5, Phase IV, Bommasandra-Jigani Link Road, Bengaluru, Karnataka 560099, India (IND)
Operations: ANALYSIS, 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.