Torrent Pharmaceuticals Limited
Form 483 issued September 26, 2022 · Indrad, India
- Inspection
- Sep 19 – Sep 26, 2022
- Investigators
- Jose E. Melendez· Pratik S. Upadhyay
- Observations
- 1
- Pages
- 15
- FEI number
- 3005029986
In short: On September 26, 2022, FDA issued a Form 483 with 1 observation to Torrent Pharmaceuticals Limited in Indrad, India (FEI 3005029986) after an inspection that ran Sep 19 – Sep 26, 2022. The investigators were Jose E. Melendez and Pratik S. Upadhyay. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would…
This inspection in context
Jose E. Melendez
44 documents · 2001–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmTorrent Pharmaceuticals Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Torrent Pharmaceuticals Limited?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Torrent Pharmaceuticals Limited?
Jose E. Melendez and Pratik S. Upadhyay are named on this Form 483, for the inspection of Sep 19 – Sep 26, 2022. Each investigator has a profile showing what they cite most.
When was Torrent Pharmaceuticals Limited inspected by FDA?
The inspection ran Sep 19 – Sep 26, 2022, and the Form 483 is dated September 26, 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.