Somerset Therapeutics Private Limited
This drug manufacturing facility is registered with the FDA by Somerset Therapeutics Private Limited. ProPublica was able to identify at least 161 generic drugs that have been manufactured at this facility.
Facility Inspection History
The FDA is responsible for inspecting drug manufacturing facilities for violations of good manufacturing practices, such as a lack of documented drug quality testing or contaminated equipment. Below is a timeline of FDA inspections and outcomes for this facility assembled by ProPublica.
Note: ProPublica does not provide medical advice. Stopping your medication, doctors warn, can be dangerous. Please consult your doctor first if you have concerns. Read more
10
Known Inspections
The inspections we were able to locate using available FDA data do not include inspections in advance of the release of a new drug product.
9
Inspections Found Issues
When issues are observed, inspectors usually file an FDA 483 form with citations. In more serious cases, the FDA can issue warning letters or even ban the import of drugs from the facility.
- Sep 4, 2025Sep 4, 2025Warning Letter
The FDA issued a warning letter laying out significant issues.
The letter is a disciplinary tool the FDA uses to lay out significant violations of manufacturing standards and to outline needed improvements. It often includes a summary of the steps the company had initially pledged to take to correct issues identified during inspections. There may be additional communications, including about issues being resolved, that are not reflected in our database because they have not been made public. - Feb 21, 2025Feb 21, 2025Inspection With Issues
The FDA ruled the facility was in an “unacceptable state of compliance.”
Inspectors found serious issues at the facility, and the agency ultimately recommended official compliance action. In cases like this, the FDA typically pauses the facility’s pending drug approvals. There may be additional communications, including about issues being resolved, that are not reflected in our database because they have not been made public.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Oct 27, 2023Oct 27, 2023Inspection With Issues
The FDA found issues but determined the facility can correct them voluntarily.
In some cases, inspectors may have recommended a different (potentially more serious) classification, but the agency declined to pursue further enforcement at the time.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Apr 4, 2022Apr 4, 2022Inspection With Issues
The FDA ruled the facility was in an “unacceptable state of compliance.”
Inspectors found serious issues at the facility, and the agency ultimately recommended official compliance action. In cases like this, the FDA typically pauses the facility’s pending drug approvals. There may be additional communications, including about issues being resolved, that are not reflected in our database because they have not been made public.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection.4 citations
Procedures not in writing, fully followedThe responsibilities and procedures applicable to the quality control unit are not in writing.Environmental Monitoring SystemAseptic processing areas are deficient regarding the system for monitoring environmental conditions.Procedures for sterile drug productsProcedures designed to prevent microbiological contamination of drug products purporting to be sterile are not written.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Aug 13, 2020Aug 13, 2020Warning Letter
The FDA issued a warning letter laying out significant issues.
The letter is a disciplinary tool the FDA uses to lay out significant violations of manufacturing standards and to outline needed improvements. It often includes a summary of the steps the company had initially pledged to take to correct issues identified during inspections. There may be additional communications, including about issues being resolved, that are not reflected in our database because they have not been made public. - Feb 19, 2020Feb 19, 2020Inspection With Issues
The FDA ruled the facility was in an “unacceptable state of compliance.”
Inspectors found serious issues at the facility, and the agency ultimately recommended official compliance action. In cases like this, the FDA typically pauses the facility’s pending drug approvals. There may be additional communications, including about issues being resolved, that are not reflected in our database because they have not been made public.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection.View Inspector NotesInspector’s notes summarizing deficiencies observed during an inspection. - Jul 23, 2019Jul 23, 2019Inspection With Issues
The FDA found issues but determined the facility can correct them voluntarily.
In some cases, inspectors may have recommended a different (potentially more serious) classification, but the agency declined to pursue further enforcement at the time.1 citation
Procedures not in writing, fully followedThe responsibilities and procedures applicable to the quality control unit are not in writing.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Dec 5, 2017Dec 5, 2017Inspection With Issues
The FDA found issues but determined the facility can correct them voluntarily.
In some cases, inspectors may have recommended a different (potentially more serious) classification, but the agency declined to pursue further enforcement at the time.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Apr 24, 2017Apr 24, 2017Inspection
The FDA determined this facility was in an acceptable state.
This is the best possible outcome for an inspection. The FDA took no compliance action and ProPublica found no issues documented by inspectors. - Oct 27, 2014Oct 27, 2014
An import ban on the facility lifted some time after this date.
The FDA doesn't publish a historic record of import alerts, but the last time we saw this facility on archived import bans lists was Oct 27, 2014. - Aug 20, 2013Aug 20, 2013Inspection With Issues
The FDA found issues but determined the facility can correct them voluntarily.
In some cases, inspectors may have recommended a different (potentially more serious) classification, but the agency declined to pursue further enforcement at the time.15 citations
GMP Training FrequencyGMP training is not conducted on a continuing basis to assure that employees remain familiar with CGMP requirements applicable to them.Training , Education , Experience overallEmployees engaged in the manufacture of a drug product lack the training required to perform their assigned functions.Written sanitation procedures lackingThere is a lack of written procedures assigning responsibility for sanitation.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Mar 27, 2012Mar 27, 2012Import Ban
The FDA banned the import of medications from this facility.
An import alert was issued for this facility, meaning the FDA had reason to believe products manufactured there violated FDA manufacturing standards and should not be allowed into the country. - Sep 20, 2011Sep 20, 2011Inspection With Issues
The FDA ruled the facility was in an “unacceptable state of compliance.”
Inspectors found serious issues at the facility, and the agency ultimately recommended official compliance action. In cases like this, the FDA typically pauses the facility’s pending drug approvals. There may be additional communications, including about issues being resolved, that are not reflected in our database because they have not been made public.ProPublica was unable to locate a 483 form detailing issues found in this inspection. - Mar 31, 2009Mar 31, 2009Inspection With Issues
The FDA found issues but determined the facility can correct them voluntarily.
In some cases, inspectors may have recommended a different (potentially more serious) classification, but the agency declined to pursue further enforcement at the time.ProPublica was unable to locate a 483 form detailing issues found in this inspection.
Drugs Manufactured Here
Below is a list of generic prescription drugs that we’ve been able to connect to this facility. Brand name and over-the-counter drugs, as well as labels we were unable to trace, are not included here.
CompanySomerset Therapeutics
Dosage
100mg/mL
Solution in a vial (4mL)
NDC: 70069-018-X
CompanySomerset Therapeutics
Dosage
200mg/mL
Solution in a vial (4mL)
NDC: 70069-019-X
CompanySomerset Therapeutics
Dosage
200mg/mL
Injection, solution in a vial (30mL)
NDC: 70069-788-04
CompanySomerset Therapeutics
Dosage
200mg/mL
Solution in a vial (30mL)
NDC: 70069-020-X
CompanySomerset Therapeutics
Dosage
1mg/mL
Solution in a vial (1mL)
NDC: 70069-641-X
CompanySomerset Therapeutics
Dosage
1%
Solution/ drops in a bottle (2mL)
NDC: 70069-581-01
CompanySomerset Therapeutics
Dosage
1%
Solution/ drops in a bottle (5mL)
NDC: 70069-582-01
CompanySomerset Therapeutics
Dosage
1%
Solution/ drops in a bottle (5mL)
NDC: 70069-716-01
CompanySomerset Therapeutics
Dosage
0.4mg/mL
White (clear colorless) solution in a vial (20mL)
NDC: 70069-481-X
CompanySomerset Therapeutics
Dosage
0.4mg/mL
Solution in a vial (1mL)
NDC: 70069-631-X
CompanySomerset Therapeutics
Dosage
1%
Solution/ drops in a bottle (15mL)
NDC: 70069-583-01
CompanyPropharma Distribution
Dosage
0.4mg/mL
Solution in a vial (1mL)
NDC: 84549-631-25
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