Lupin Ltd. 28-1, Midc Industrial Area, Chikalthana
Form 483 issued May 15, 2019 · Aurangabad, India
- Inspection
- May 6 – May 15, 2019
- Investigator
- Rumany C. Penn
- Observations
- 2
- Pages
- 2
- FEI number
- 3004995645
In short: On May 15, 2019, FDA issued a Form 483 with 2 observations to Lupin Ltd. 28-1, Midc Industrial Area, Chikalthana in Aurangabad, India (FEI 3004995645) after an inspection that ran May 6 – May 15, 2019. The investigator was Rumany C. Penn. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records of investigations into unexplained discrepancies and the failure of a batch or any of…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans…
This inspection in context
Rumany C. Penn
21 documents · 2016–2022
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmLupin Ltd. 28-1, Midc Industrial Area, Chikalthana 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 Ltd. 28-1, Midc Industrial Area, Chikalthana?
FDA listed 2 observations on this Form 483, mostly about quality system and laboratory controls. 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 Ltd. 28-1, Midc Industrial Area, Chikalthana?
Rumany C. Penn is named on this Form 483, for the inspection of May 6 – May 15, 2019. Each investigator has a profile showing what they cite most.
When was Lupin Ltd. 28-1, Midc Industrial Area, Chikalthana inspected by FDA?
The inspection ran May 6 – May 15, 2019, and the Form 483 is dated May 15, 2019.
How do I get the full Form 483 for Lupin Ltd. 28-1, Midc Industrial Area, Chikalthana?
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.