Torrent Pharmaceuticals Limited
Form 483 issued May 25, 2023 · Bharuch, India
- Inspection
- May 17 – May 25, 2023
- Investigator
- Kellia N. Hicks
- Observations
- 2
- Pages
- 4
- FEI number
- 3010228235
In short: On May 25, 2023, FDA issued a Form 483 with 2 observations to Torrent Pharmaceuticals Limited in Bharuch, Gujarat (FEI 3010228235) after an inspection that ran May 17 – May 25, 2023. The investigator was Kellia N. Hicks. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.68(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Kellia N. Hicks
28 documents · 2017–2025
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 2 observations on this Form 483, mostly about quality system and facilities & equipment. 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?
Kellia N. Hicks is named on this Form 483, for the inspection of May 17 – May 25, 2023. Each investigator has a profile showing what they cite most.
When was Torrent Pharmaceuticals Limited inspected by FDA?
The inspection ran May 17 – May 25, 2023, and the Form 483 is dated May 25, 2023.
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.