Jubilant Generics Limited
Form 483 issued February 2, 2024 · Roorkee, India
- Inspection
- Jan 25 – Feb 2, 2024
- Investigators
- Jeffrey P. Raimondi· Tamil Arasu
- Observations
- 4
- Pages
- 6
- FEI number
- 3006895982
In short: On February 2, 2024, FDA issued a Form 483 with 4 observations to Jubilant Generics Limited in Roorkee, India (FEI 3006895982) after an inspection that ran Jan 25 – Feb 2, 2024. The investigators were Jeffrey P. Raimondi and Tamil Arasu. Most observations concern quality system and production.
At a glance
Quality system and production account for 4 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
Written records are not always made of…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
Time limits are not established when appropriate for the completion of each production phase to assure…
- 04
Control procedures are not established which validate the performance of those manufacturing processes that may be…
This inspection in context
Jeffrey P. Raimondi
40 documents · 2017–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
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?
Jeffrey P. Raimondi and Tamil Arasu are named on this Form 483, for the inspection of Jan 25 – Feb 2, 2024. Each investigator has a profile showing what they cite most.
When was Jubilant Generics Limited inspected by FDA?
The inspection ran Jan 25 – Feb 2, 2024, and the Form 483 is dated February 2, 2024.
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.