Jubilant Generics Limited
Form 483 issued August 8, 2018 · Roorkee, India
- Inspection
- Jul 30 – Aug 8, 2018
- Investigator
- Unnee Ranjan
- Observations
- 4
- Pages
- 7
- FEI number
- 3006895982
In short: On August 8, 2018, FDA issued a Form 483 with 4 observations to Jubilant Generics Limited in Roorkee, Uttarakhand (FEI 3006895982) after an inspection that ran Jul 30 – Aug 8, 2018. The investigator was Unnee Ranjan. Most observations concern quality system and production.
At a glance
Quality system and production account for 3 of 4 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
Written records of investigation of a drug complaint do not include the findings of the…
- 03
Written procedures are not followed that describe the in-process controls and tests to be conducted on…
- 04
eld Alert Report was not submitted within three working days of receipt of information concerning a…
This inspection in context
Unnee Ranjan
30 documents · 2015–2026
Cites 211.67 (equipment cleaning and maintenance) 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 4 observations on this Form 483, mostly about quality system and production. The opening words of each observation are shown on this page.
Who inspected Jubilant Generics Limited?
Unnee Ranjan is named on this Form 483, for the inspection of Jul 30 – Aug 8, 2018. Each investigator has a profile showing what they cite most.
When was Jubilant Generics Limited inspected by FDA?
The inspection ran Jul 30 – Aug 8, 2018, and the Form 483 is dated August 8, 2018.
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.