Jubilant Biosys Limited
Form 483 issued December 18, 2018 · Nanjangud, India
- Inspection
- Dec 10 – Dec 18, 2018
- Observations
- 12
- Pages
- 10
- FEI number
- 3003144728
In short: On December 18, 2018, FDA issued a Form 483 with 12 observations to Jubilant Biosys Limited in Nanjangud, Mysuru (FEI 3003144728) after an inspection that ran Dec 10 – Dec 18, 2018. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and laboratory controls account for 10 of 12 observations.
Most cited: 21 CFR 211.67 (4×) · 211.160 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Investigations are inadequate in that they do not evaluate all potential root causes of unexpected results…
- 02
Validated and/or transferred analytical methods…
- 03
The validation of your firm's cleaning process for non-dedicated equipment is deficient in that the cleaning…
- 04
(REPEAT OBSERVATION) Non-dedicated equipment used to manufacture drug substances is not maintained clean. . ©) 4)…
This inspection in context
Questions about this 483
What did FDA find at Jubilant Biosys Limited?
FDA listed 12 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
When was Jubilant Biosys Limited inspected by FDA?
The inspection ran Dec 10 – Dec 18, 2018, and the Form 483 is dated December 18, 2018.
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.