Torrent Pharmaceuticals Limited Unit - 2, 105 106 119 Survey No 102
Form 483 issued December 11, 2023 · Gandhinagar, India
- Inspection
- Dec 5 – Dec 11, 2023
- Investigator
- Yvins Dezan
- Observations
- 5
- Pages
- 6
- FEI number
- 3012740315
In short: On December 11, 2023, FDA issued a Form 483 with 5 observations to Torrent Pharmaceuticals Limited Unit - 2, 105 106 119 Survey No 102 in Gandhinagar, Gujarat (FEI 3012740315) after an inspection that ran Dec 5 – Dec 11, 2023. The investigator was Yvins Dezan. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Quality system and facilities & equipment account for 3 of 5 observations.
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…
- 02
The responsibilities and procedures applicable to the quality unit are not in writing and fully followed…
- 03
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent malfunctions and contamination…
- 04
Components for drug product manufacturing are…
This inspection in context
Yvins Dezan
27 documents · 2017–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmTorrent Pharmaceuticals Limited Unit - 2, 105 106 119 Survey No 102 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 Unit - 2, 105 106 119 Survey No 102?
FDA listed 5 observations on this Form 483, mostly about quality system, facilities & equipment and production. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Torrent Pharmaceuticals Limited Unit - 2, 105 106 119 Survey No 102?
Yvins Dezan is named on this Form 483, for the inspection of Dec 5 – Dec 11, 2023. Each investigator has a profile showing what they cite most.
When was Torrent Pharmaceuticals Limited Unit - 2, 105 106 119 Survey No 102 inspected by FDA?
The inspection ran Dec 5 – Dec 11, 2023, and the Form 483 is dated December 11, 2023.
How do I get the full Form 483 for Torrent Pharmaceuticals Limited Unit - 2, 105 106 119 Survey No 102?
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.