Torrent Pharmaceuticals Limited
Form 483 issued September 20, 2024 · Pithampur, India
- Inspection
- Sep 16 – Sep 20, 2024
- Investigators
- Karen A. Briggs· Lillian S. Wu
- Observations
- 1
- Pages
- 1
- FEI number
- 3008861587
In short: On September 20, 2024, FDA issued a Form 483 with 1 observation to Torrent Pharmaceuticals Limited in Pithampur, Madhya Pradesh (FEI 3008861587) after an inspection that ran Sep 16 – Sep 20, 2024. The investigators were Karen A. Briggs and Lillian S. Wu. Most observations concern materials; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
1 of 1 observations on this 483 concern materials.
Most cited: 21 CFR 211.84 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The identity of each component of a drug product is not verified by conducting at least…
This inspection in context
Karen A. Briggs
19 documents · 2021–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Virginia.
The firmTorrent Pharmaceuticals Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.84
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 materials. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Torrent Pharmaceuticals Limited?
Karen A. Briggs and Lillian S. Wu are named on this Form 483, for the inspection of Sep 16 – Sep 20, 2024. Each investigator has a profile showing what they cite most.
When was Torrent Pharmaceuticals Limited inspected by FDA?
The inspection ran Sep 16 – Sep 20, 2024, and the Form 483 is dated September 20, 2024.
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.