Somerset Theraoeutics Private Limited
Form 483 issued April 4, 2022 · Bengaluru, India
- Inspection
- Mar 24 – Apr 4, 2022
- Observations
- 4
- Pages
- 8
- FEI number
- 3003821988
In short: On April 4, 2022, FDA issued a Form 483 with 4 observations to Somerset Theraoeutics Private Limited in Bengaluru, Karnataka (FEI 3003821988) after an inspection that ran Mar 24 – Apr 4, 2022. Most observations concern quality system and production.
At a glance
Quality system and production account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 04
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
Questions about this 483
What did FDA find at Somerset Theraoeutics Private Limited?
FDA listed 4 observations on this Form 483, mostly about quality system, production and facilities & equipment. The opening words of each observation are shown on this page.
When was Somerset Theraoeutics Private Limited inspected by FDA?
The inspection ran Mar 24 – Apr 4, 2022, and the Form 483 is dated April 4, 2022.
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.