Site records / Karnataka / FEI 3003821988
Somerset Therapeutics Private LimitedBengaluru, Karnataka
FDA-registered drug establishment in Bengaluru, Karnataka: analysis, label, manufacture, pack. Registration valid to 31 Dec 2026. Record as observed 27 Sep 2026.
- Inspections posted
- 10
- Last inspection
- Feb 2025 · OAI
- Warning letters to this FEI
- 3
- 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
10 FDA inspections of this FEI, by end date; 10 with a posted classification.
- 21 Feb 2025OAI · Official Action IndicatedDrug Quality Assurance · no citations posted
- 27 Oct 2023VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 4 Apr 2022OAI · Official Action IndicatedDrug Quality Assurance · 4 citations posted
- 19 Feb 2020OAI · Official Action IndicatedDrug Quality Assurance · no citations posted
- 23 Jul 2019VAI · Voluntary Action IndicatedDrug Quality Assurance · 1 citation posted
- 5 Dec 2017VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 24 Apr 2017NAI · No Action IndicatedDrug Quality Assurance · no citations posted
- 20 Aug 2013VAI · Voluntary Action IndicatedDrug Quality Assurance · 15 citations posted
- 20 Sep 2011OAI · Official Action IndicatedDrug Quality Assurance · no citations posted
- 31 Mar 2009VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
Warning letters and compliance actions
- 4 Sep 2025Warning Letter · CDER SourceCGMP/Finished Pharmaceuticals/Adulterated
- 13 Aug 2020Warning Letter · CDER
- 23 Feb 2012Warning Letter · CDER
Import alerts in force
No listing in force under this firm's name.
Form 483s released by FDA
- 21 Feb 2025Form 483 · 11 pages Source
Registration
- FEI
- 3003821988
- DUNS
- 677236695
- Registered as
- Somerset Therapeutics Private Limited
- Registrant
- Somerset Therapeutics Private Limited
- Address
- 54/1, Boodihal Village Nelamangala Taluk, Bengaluru, Karnataka 562123, 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.