Somerset Theraoeutics Private Limited
Form 483 issued February 19, 2020 · Bengaluru, India
- Inspection
- Feb 18 – Feb 19, 2020
- Investigators
- Linda F. Murphy· Steven M. Weinman
- Observations
- 6
- Pages
- 7
- FEI number
- 3003821988
In short: On February 19, 2020, FDA issued a Form 483 with 6 observations to Somerset Theraoeutics Private Limited in Bengaluru, Karnataka (FEI 3003821988) after an inspection that ran Feb 18 – Feb 19, 2020. The investigators were Linda F. Murphy and Steven M. Weinman. Most observations concern production and materials; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and materials account for 4 of 6 observations.
Most cited: 21 CFR 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
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 03
Drug product containers or closures are additive so as to alter the safety, identity, strength, quality…
- 04
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Linda F. Murphy
23 documents · 2015–2020
Cites 211.42 (design and construction features) 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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Somerset Theraoeutics Private Limited?
FDA listed 6 observations on this Form 483, mostly about production, materials and quality system. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Somerset Theraoeutics Private Limited?
Linda F. Murphy and Steven M. Weinman are named on this Form 483, for the inspection of Feb 18 – Feb 19, 2020. Each investigator has a profile showing what they cite most.
When was Somerset Theraoeutics Private Limited inspected by FDA?
The inspection ran Feb 18 – Feb 19, 2020, and the Form 483 is dated February 19, 2020.
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.