Torrent Pharmaceuticals Limited
Form 483 issued September 28, 2022 · Indrad, India
- Inspection
- Sep 19 – Sep 28, 2022
- Observations
- 3
- Pages
- 15
- FEI number
- 3005029956
In short: On September 28, 2022, FDA issued a Form 483 with 3 observations to Torrent Pharmaceuticals Limited in Indrad, Gujarat (FEI 3005029956) after an inspection that ran Sep 19 – Sep 28, 2022. Most observations concern quality system and facilities & equipment.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observation- 01
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination ‘that would…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
Written records of investigation of a drug complaint do not include the findings of the…
This inspection in context
Questions about this 483
What did FDA find at Torrent Pharmaceuticals Limited?
FDA listed 3 observations on this Form 483, mostly about quality system and facilities & equipment. The opening words of each observation are shown on this page.
When was Torrent Pharmaceuticals Limited inspected by FDA?
The inspection ran Sep 19 – Sep 28, 2022, and the Form 483 is dated September 28, 2022.
How do I get the full Form 483 for Torrent Pharmaceuticals 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.