Jubilant Generics Limited
Form 483 issued March 12, 2021 · Hardiwar, India
- Inspection
- Mar 2 – Mar 12, 2021
- Investigators
- Dipesh K. Shah· Rita K. Kabaso
- Observations
- 7
- Pages
- 16
- FEI number
- 3006895982
In short: On March 12, 2021, FDA issued a Form 483 with 7 observations to Jubilant Generics Limited in Hardiwar, Uttarakhand (FEI 3006895982) after an inspection that ran Mar 2 – Mar 12, 2021. The investigators were Dipesh K. Shah and Rita K. Kabaso. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and quality system account for 5 of 7 observations.
Most cited: 21 CFR 211.68 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment and utensils are not cleaned, maintained, and sanitized at appropriate intervals to prevent malfunctions and…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate, sampling plans designed to…
- 03
Investigations of any unexplained discrepancy, a failure of a batch or any of its components to…
- 04
Control procedures are not established which validate the performance of those manufacturing processes that may be…
This inspection in context
Dipesh K. Shah
29 documents · 2006–2026
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 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Jubilant Generics Limited?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Jubilant Generics Limited?
Dipesh K. Shah and Rita K. Kabaso are named on this Form 483, for the inspection of Mar 2 – Mar 12, 2021. Each investigator has a profile showing what they cite most.
When was Jubilant Generics Limited inspected by FDA?
The inspection ran Mar 2 – Mar 12, 2021, and the Form 483 is dated March 12, 2021.
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.