Torrent Pharmaceuticals Limited Ahmedabad Mehsana Highway
Form 483 issued April 28, 2017 · Indrad, India
- Inspection
- Apr 17 – Apr 28, 2017
- Investigators
- Djamila Harouaka· Gam S. Zamil
- Observations
- 1
- Pages
- 5
- FEI number
- 3005029956
In short: On April 28, 2017, FDA issued a Form 483 with 1 observation to Torrent Pharmaceuticals Limited Ahmedabad Mehsana Highway in Indrad, India (FEI 3005029956) after an inspection that ran Apr 17 – Apr 28, 2017. The investigators were Djamila Harouaka and Gam S. Zamil. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality unit…
This inspection in context
Djamila Harouaka
15 documents · 2015–2023
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmTorrent Pharmaceuticals Limited Ahmedabad Mehsana Highway history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Torrent Pharmaceuticals Limited Ahmedabad Mehsana Highway?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Torrent Pharmaceuticals Limited Ahmedabad Mehsana Highway?
Djamila Harouaka and Gam S. Zamil are named on this Form 483, for the inspection of Apr 17 – Apr 28, 2017. Each investigator has a profile showing what they cite most.
When was Torrent Pharmaceuticals Limited Ahmedabad Mehsana Highway inspected by FDA?
The inspection ran Apr 17 – Apr 28, 2017, and the Form 483 is dated April 28, 2017.
How do I get the full Form 483 for Torrent Pharmaceuticals Limited Ahmedabad Mehsana Highway?
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.