Somerset Theraoeutics Private Limited
Form 483 issued February 21, 2025 · Bengaluru, India
- Inspection
- Feb 10 – Feb 21, 2025
- Investigators
- Eileen A. Liu· Joseph A. Piechocki
- Observations
- 9
- Pages
- 11
- FEI number
- 3003821988
In short: On February 21, 2025, FDA issued a Form 483 with 9 observations to Somerset Theraoeutics Private Limited in Bengaluru, India (FEI 3003821988) after an inspection that ran Feb 10 – Feb 21, 2025. The investigators were Eileen A. Liu and Joseph A. Piechocki. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Production and facilities & equipment account for 6 of 9 observations.
Most cited: 21 CFR 211.42 (3×) · 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to submit a field alert report (FAR) to FDA within 3 working…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
This inspection in context
Eileen A. Liu
41 documents · 2014–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmSomerset Theraoeutics Private Limited history
All 7 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Somerset Theraoeutics Private Limited?
FDA listed 9 observations on this Form 483, mostly about production, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Somerset Theraoeutics Private Limited?
Eileen A. Liu and Joseph A. Piechocki are named on this Form 483, for the inspection of Feb 10 – Feb 21, 2025. Each investigator has a profile showing what they cite most.
When was Somerset Theraoeutics Private Limited inspected by FDA?
The inspection ran Feb 10 – Feb 21, 2025, and the Form 483 is dated February 21, 2025.
How do I get the full Form 483 for Somerset Theraoeutics Private Limited?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.