Lupin Limited (Unit II)
Form 483 issued August 12, 2016 · Madhya Pradesh, India
- Inspection
- Aug 8 – Aug 12, 2016
- Investigator
- Charanjeet S. Jassal
- Observations
- 4
- Pages
- 4
- FEI number
- 3007756473
In short: On August 12, 2016, FDA issued a Form 483 with 4 observations to Lupin Limited (Unit II) in Madhya Pradesh, India (FEI 3007756473) after an inspection that ran Aug 8 – Aug 12, 2016. The investigator was Charanjeet S. Jassal. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
3 of 4 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Investigations of a failure of a batch or any of its components to meet any of…
- 02
Written records are not made of investigations into unexplained discrepancies which may impact the strength, purity…
- 03
Written records of investigation of an active pharmaceutical ingredient (API) complaint…
- 04
Equipment is not maintained at appropriate intervals to prevent malfunctions that would alter the safety, identity…
This inspection in context
Charanjeet S. Jassal
5 documents · 2015–2016
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmLupin Limited (Unit II) history
All 2 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 (Unit II)?
FDA listed 4 observations on this Form 483, mostly about quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Lupin Limited (Unit II)?
Charanjeet S. Jassal is named on this Form 483, for the inspection of Aug 8 – Aug 12, 2016. Each investigator has a profile showing what they cite most.
When was Lupin Limited (Unit II) inspected by FDA?
The inspection ran Aug 8 – Aug 12, 2016, and the Form 483 is dated August 12, 2016.
How do I get the full Form 483 for Lupin Limited (Unit II)?
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.