Drug establishmentActive, Registered FY2026FDA warning letter on file

Somerset Therapeutics Private Limited

Somerset Therapeutics Private Limited is an FDA-registered drug establishment (FEI 3003821988) located in . The facility is active, registered for FY2026. FDA has issued 1 warning letter(s) to this facility.

FDA warning letter

Sep 4, 2025

CGMP/Finished Pharmaceuticals/Adulterated

Read the letter on FDA.gov ›

A warning letter is FDA's formal notice of significant violations that require prompt correction. It can hold up product approvals, trigger import alerts, and put supply agreements at risk until the issues are resolved and FDA closes it out.

Recalls (4)

Nov 26, 2025 Class III

Subpotent product:out of specification assay results observed during long term stability testing.

Ongoing

Mar 21, 2025 Class II

Lack of Assurance of Sterility: Media fill with bacterial contamination

Ongoing

Apr 24, 2024 Class II

Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).

Ongoing

Jun 4, 2020 Class III

Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.

Terminated

Recall data from openFDA enforcement reports (FDA Recall Enterprise System).

Establishment record

FEI Number

3003821988

Address

54/1, ,

Establishment type

Drug establishment

Products / operations

ANALYSIS; LABEL; MANUFACTURE; PACK

Registration status

Active, Registered FY2026

Verify this record on FDA.gov ›

Inspection history

Inspections on file

None on file

Form 483 observations

None on file

FDA publishes only a subset of inspection records and Form 483s, so "None on file" is not a guarantee of a clean inspection history.

Questions

Is Somerset Therapeutics Private Limited registered with the FDA?

Yes. Somerset Therapeutics Private Limited is an FDA-registered drug establishment (FEI 3003821988) in . Its current registration status is Active, Registered FY2026.

Has Somerset Therapeutics Private Limited received an FDA warning letter?

Yes. FDA issued a warning letter to Somerset Therapeutics Private Limited; the most recent is dated Sep 4, 2025 (CGMP/Finished Pharmaceuticals/Adulterated).

What does Somerset Therapeutics Private Limited do?

Somerset Therapeutics Private Limited's FDA-registered operations are: ANALYSIS; LABEL; MANUFACTURE; PACK.

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Source: FDA public data · status as of 2026-06-01