Torrent Pharmaceuticals Limited Ahmedabad Mehsana Highway, Taluka-Kadi
Form 483 issued April 16, 2019 · Indrad, India
- Inspection
- Apr 8 – Apr 16, 2019
- Investigators
- Lata Mathew· Zhao Wang
- Observations
- 1
- Pages
- 17
- FEI number
- 3005029956
In short: On April 16, 2019, FDA issued a Form 483 with 1 observation to Torrent Pharmaceuticals Limited Ahmedabad Mehsana Highway, Taluka-Kadi in Indrad, India (FEI 3005029956) after an inspection that ran Apr 8 – Apr 16, 2019. The investigators were Lata Mathew and Zhao Wang. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Lata Mathew
24 documents · 2017–2024
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmTorrent Pharmaceuticals Limited Ahmedabad Mehsana Highway, Taluka-Kadi history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Torrent Pharmaceuticals Limited Ahmedabad Mehsana Highway, Taluka-Kadi?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Torrent Pharmaceuticals Limited Ahmedabad Mehsana Highway, Taluka-Kadi?
Lata Mathew and Zhao Wang are named on this Form 483, for the inspection of Apr 8 – Apr 16, 2019. Each investigator has a profile showing what they cite most.
When was Torrent Pharmaceuticals Limited Ahmedabad Mehsana Highway, Taluka-Kadi inspected by FDA?
The inspection ran Apr 8 – Apr 16, 2019, and the Form 483 is dated April 16, 2019.
How do I get the full Form 483 for Torrent Pharmaceuticals Limited Ahmedabad Mehsana Highway, Taluka-Kadi?
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.