Torrent Pharmaceuticals Limited
Form 483 issued March 19, 2019 · Bharuch, India
- Inspection
- Mar 11 – Mar 19, 2019
- Investigator
- Guerlain Ulysse
- Observations
- 5
- Pages
- 7
- FEI number
- 3010228235
In short: On March 19, 2019, FDA issued a Form 483 with 5 observations to Torrent Pharmaceuticals Limited in Bharuch, Gujarat (FEI 3010228235) after an inspection that ran Mar 11 – Mar 19, 2019. The investigator was Guerlain Ulysse. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
4 of 5 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (3×)
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 whether or not the batch…
- 02
Laboratory records are deficient in that they do not include a complete record of all…
- 03
All records of production, control and distribution associated with a batch of drug product were not…
- 04
Batch production and control records do not include the results of any investigation made into any…
This inspection in context
Guerlain Ulysse
32 documents · 2016–2026
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
All 2 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?
FDA listed 5 observations on this Form 483, mostly about quality system and laboratory controls. 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?
Guerlain Ulysse is named on this Form 483, for the inspection of Mar 11 – Mar 19, 2019. Each investigator has a profile showing what they cite most.
When was Torrent Pharmaceuticals Limited inspected by FDA?
The inspection ran Mar 11 – Mar 19, 2019, and the Form 483 is dated March 19, 2019.
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.