Lupin Limited
Form 483 issued January 25, 2019 · Pithampur, India
- Inspection
- Jan 14 – Jan 25, 2019
- Investigators
- Jogy George· Yvins Dezan
- Observations
- 6
- Pages
- 20
- FEI number
- 3007549629
In short: On January 25, 2019, FDA issued a Form 483 with 6 observations to Lupin Limited in Pithampur, India (FEI 3007549629) after an inspection that ran Jan 14 – Jan 25, 2019. The investigators were Jogy George and Yvins Dezan. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 5 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Written records of investigation of a drug complaint do not include the findings of the…
- 03
Employees engaged in the manufacture, processing, packing and holding of a drug product lack the training…
- 04
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Jogy George
15 documents · 2016–2023
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in India.
The firmLupin Limited history
All 5 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 Lupin Limited?
FDA listed 6 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Lupin Limited?
Jogy George and Yvins Dezan are named on this Form 483, for the inspection of Jan 14 – Jan 25, 2019. Each investigator has a profile showing what they cite most.
When was Lupin Limited inspected by FDA?
The inspection ran Jan 14 – Jan 25, 2019, and the Form 483 is dated January 25, 2019.
How do I get the full Form 483 for Lupin 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.