Site records / Tamil Nadu / FEI 3004540907
OrBion Pharmaceuticals Private LimitedKancheepuram, Tamil Nadu
FDA-registered drug establishment in Kancheepuram, Tamil Nadu: analysis, label, manufacture, pack. Registration valid to 31 Dec 2026. Record as observed 27 Sep 2026.
- Inspections posted
- 6
- Last inspection
- Oct 2025 · NAI
- 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
6 FDA inspections of this FEI, by end date; 6 with a posted classification.
- 27 Oct 2025NAI · No Action IndicatedDrug Quality Assurance · no citations posted
- 8 Sep 2023VAI · Voluntary Action IndicatedDrug Quality Assurance · 3 citations posted
- 31 May 2019VAI · Voluntary Action IndicatedDrug Quality Assurance · 5 citations posted
- 3 Jun 2015VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 14 Jun 2013NAI · No Action IndicatedDrug Quality Assurance · no citations posted
- 7 Apr 2011VAI · 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.
Registration
- FEI
- 3004540907
- DUNS
- 854403569
- Registered as
- OrBion Pharmaceuticals Private Limited
- Registrant
- Bionpharma Inc.
- Address
- Plot No.B5 (Part) and B6 (Part), SIPCOT Industrial Park, Irungattukottai, Sriperumbudur, Kancheepuram, TAMIL NADU 602117, India (IND)
- Operations
- ANALYSIS, LABEL, 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.