Jubilant Generics Limited
Form 483 issued August 1, 2022 · Sikanderpur Bhainswal, India
- Inspection
- Jul 20 – Aug 1, 2022
- Investigators
- Rajiv R. Srivastava· Yvins Dezan
- Observations
- 6
- Pages
- 14
- FEI number
- 3006895982
In short: On August 1, 2022, FDA issued a Form 483 with 6 observations to Jubilant Generics Limited in Sikanderpur Bhainswal, India (FEI 3006895982) after an inspection that ran Jul 20 – Aug 1, 2022. The investigators were Rajiv R. Srivastava and Yvins Dezan. 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 6 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (3×)
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
Written records are not always made of…
- 03
Written records of investigations into unexplained discrepancies do not always include…
- 04
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
Rajiv R. Srivastava
30 documents · 2018–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmJubilant Generics Limited 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 Jubilant Generics Limited?
FDA listed 6 observations on this Form 483, mostly about quality system, laboratory controls and production. 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 Jubilant Generics Limited?
Rajiv R. Srivastava and Yvins Dezan are named on this Form 483, for the inspection of Jul 20 – Aug 1, 2022. Each investigator has a profile showing what they cite most.
When was Jubilant Generics Limited inspected by FDA?
The inspection ran Jul 20 – Aug 1, 2022, and the Form 483 is dated August 1, 2022.
How do I get the full Form 483 for Jubilant Generics 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.