Lupin Limited 7-142, M.I.D.C. Tarapur Via Boisar
Form 483 issued April 4, 2022 · Tarapur, India
- Inspection
- Mar 22 – Apr 4, 2022
- Observations
- 4
- Pages
- 8
- FEI number
- 3002807512
In short: On April 4, 2022, FDA issued a Form 483 with 4 observations to Lupin Limited 7-142, M.I.D.C. Tarapur Via Boisar in Tarapur, Maharashtra (FEI 3002807512) after an inspection that ran Mar 22 – Apr 4, 2022. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 3 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
Your existing procedures and processes for the manufacture of APIs are inadequate to ensure that the…
- 02
Your firm’s cleaning processes for dedicated as well as for non-dedicated equipment have not been…
- 03
You have not established in-process sampling and controls to monitor the progress and control the performance…
- 04
Investigations are inadequate in that the quality unit did not evaluate all potential root causes for…
This inspection in context
Questions about this 483
What did FDA find at Lupin Limited 7-142, M.I.D.C. Tarapur Via Boisar?
FDA listed 4 observations on this Form 483, mostly about production, facilities & equipment and quality system. The opening words of each observation are shown on this page.
When was Lupin Limited 7-142, M.I.D.C. Tarapur Via Boisar inspected by FDA?
The inspection ran Mar 22 – Apr 4, 2022, and the Form 483 is dated April 4, 2022.
How do I get the full Form 483 for Lupin Limited 7-142, M.I.D.C. Tarapur Via Boisar?
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.