Jubilant Biosys Limited
Form 483 issued December 13, 2022 · Nanjangud, India
- Inspection
- Dec 5 – Dec 13, 2022
- Observations
- 8
- Pages
- 18
- FEI number
- 3003144728
In short: On December 13, 2022, FDA issued a Form 483 with 8 observations to Jubilant Biosys Limited in Nanjangud, Mysuru (FEI 3003144728) after an inspection that ran Dec 5 – Dec 13, 2022. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Quality system and facilities & equipment account for 6 of 8 observations.
Most cited: 21 CFR 211.100 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure of quality unit to exercise its responsibility to ensure the Active Pharmaceutical Ingredients (API) manufactured…
- 02
REPEAT OBSERVATION Investigations are inadequate in that they do not evaluate all potential root causes of…
- 03
Employees engaged in the manufacture, processing, packing, holding of finished APIs lack the training required to…
- 04
REPEAT OBSERVATION Equipment and utensils are not cleaned, maintained, and sanitized at appropriate intervals to prevent…
This inspection in context
Questions about this 483
What did FDA find at Jubilant Biosys Limited?
FDA listed 8 observations on this Form 483, mostly about quality system, facilities & equipment and production. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
When was Jubilant Biosys Limited inspected by FDA?
The inspection ran Dec 5 – Dec 13, 2022, and the Form 483 is dated December 13, 2022.
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.