Site records / Karnataka / FEI 3010164491
Biocon LimitedBengaluru, Karnataka
FDA-registered drug establishment in Bengaluru, Karnataka: analysis, api manufacture. Registration valid to 31 Dec 2026. Record as observed 27 Sep 2026.
- Inspections posted
- 3
- Last inspection
- Sep 2024 · VAI
- Warning letters to this FEI
- 0
- Import alerts at this address
- 0
- US border refusals, 2 years
- 0
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.
- 27 Sep 2024VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 24 Jan 2020VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 8 Jul 2016NAI · No 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
- 24 Jan 2020Form 483 · 4 pages Source
Other registered sites of Biocon
- Biocon Pharma LimitedBengaluru, Karnataka
- Biocon Biologics LimitedBengaluru, Karnataka
- Biocon Biologics LimitedBengaluru, Karnataka
- Biocon Biosphere LimitedAnakapalli, Andhra Pradesh
- Biocon LimitedBengaluru, Karnataka
- Biocon LimitedSangareddy, Telangana
- Biocon LimitedAnakapalli, Andhra Pradesh
Registration
- FEI
- 3010164491
- DUNS
- 915076162
- Registered as
- Biocon Limited
- Registrant
- Biocon Limited
- Address
- Special Economic Zone, Plot No. 2, 3, 4 & 5, Phase IV, Bommasandra-Jigani Link Road, Bommasandra Post, Bengaluru, Karnataka 560099, India (IND)
- Operations
- ANALYSIS, 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.