Jubilant Biosys Limited
Form 483 issued October 27, 2017 · Nanjangud, India
- Inspection
- Oct 27, 2017
- Observations
- 4
- Pages
- 5
- FEI number
- 3003144728
In short: On October 27, 2017, FDA issued a Form 483 with 4 observations to Jubilant Biosys Limited in Nanjangud, Mysuru (FEI 3003144728) after an inspection that ran Oct 27, 2017. Most observations concern quality system and facilities & equipment.
At a glance
Observations span 2 systems, led by quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
APIs failing ongoing long-term stability while the products are…
- 02
Complaints are not investigated thoroughly. A. Non-conforming commercial APY batches identified in customer complaints are…
- 03
Facilities aad Manufacturing equipment is not maintained clean to prevent contamination. ® (Or) A. Some visible…
- 04
There is no assurance shipped APIs are not impacted…
This inspection in context
Questions about this 483
What did FDA find at Jubilant Biosys Limited?
FDA listed 4 observations on this Form 483, mostly about quality system and facilities & equipment. The opening words of each observation are shown on this page.
When was Jubilant Biosys Limited inspected by FDA?
The inspection ran Oct 27, 2017, and the Form 483 is dated October 27, 2017.
How do I get the full Form 483 for Jubilant Biosys 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.