Somerset Theraoeutics Private Limited
FDA inspection history across 3 sites, 2012 to 2025
- 3
- Form 483s
- 2
- Warning letters
- 2
- Close-outs
Every document, by year
- Warning letter
- Form 483
- Close-out
2012: one warning letter; 2014: one close-out letter; 2020: one close-out letter and one Form 483; 2022: one Form 483; 2025: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2012–14One warning letter and one close-out letter, at Bangalore, India.
- 2020–22Two Form 483s and one close-out letter, at Somerset, New Jersey and Bengaluru, India.
- 2025One warning letter and one Form 483, at Somerset, New Jersey and Bengaluru, India.
- 2025The longest 483 on file: 9 observations over 11 pages at Bengaluru, India.
Cited most
Across all Somerset Theraoeutics Private Limited observations on file
- 21 CFR 211.113Control of microbiological contamination5
- 21 CFR 211.42Design and construction features4
- 21 CFR 211.160General requirements2
- 21 CFR 211.192Production record review2
- 21 CFR 211.22Responsibilities of quality control unit2
The complete Somerset Theraoeutics Private Limited file.
All 7 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Bengaluru, India
Three Form 483s · 2020 to 2025 · 19 observations
Latest: Form 483, Feb 21, 2025 →Somerset, New Jersey
One warning letter and one close-out letter · 2020 to 2025
Latest: Warning letter, Sep 4, 2025 →Bangalore, India
One close-out letter · 2014
Latest: Close-out, Jun 18, 2014 →
Also: one document not tied to a site.
Documents
7 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-09-04 | Warning letter Warning letter | Somerset, New Jersey | — | $99 |
| 2025-02-21 | 483 Form 483 | Bengaluru, India | 9 | $99 |
| 2022-04-04 | 483 Form 483 | Bengaluru, India | 4 | $99 |
| 2020-08-13 | Close-out Close-out letter | Somerset, New Jersey | — | $99 |
| 2020-02-19 | 483 Form 483 | Bengaluru, India | 6 | $99 |
| 2014-06-18 | Close-out Close-out letter | Bangalore, India | — | $99 |
| 2012-02-23 | Warning letter Warning letter | — | — | $99 |
Investigators on these documents
Eileen A. Liu (1)Joseph A. Piechocki (1)Linda F. Murphy (1)Steven M. Weinman (1)
FEI number 3003821988 · most recent document Sep 4, 2025
About Somerset Theraoeutics Private Limited
How many FDA Form 483s has Somerset Theraoeutics Private Limited received?
FDA Intel has 3 Form 483s on file for Somerset Theraoeutics Private Limited; the most recent is dated Feb 21, 2025.
When was Somerset Theraoeutics Private Limited last inspected by FDA?
The most recent FDA inspection document on file for Somerset Theraoeutics Private Limited is a Form 483 dated Feb 21, 2025, for the site in Bengaluru, India.
What did FDA cite at Somerset Theraoeutics Private Limited?
The regulations cited most in the observations on file for Somerset Theraoeutics Private Limited are 21 CFR 211.113 (Control of microbiological contamination), 5 times; 21 CFR 211.42 (Design and construction features), 4 times; 21 CFR 211.160 (General requirements), 2 times.
Has Somerset Theraoeutics Private Limited received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for Somerset Theraoeutics Private Limited; the most recent is dated Sep 4, 2025.