Lupin Ltd. 28-1, Midc Industrial Area, Chikalthana
Form 483 issued March 15, 2024 · Aurangabad, India
- Inspection
- Mar 6 – Mar 15, 2024
- Investigators
- Lisa L. Flores· Vaishali J. Patel
- Observations
- 1
- Pages
- 1
- FEI number
- 3004995645
In short: On March 15, 2024, FDA issued a Form 483 with 1 observation to Lupin Ltd. 28-1, Midc Industrial Area, Chikalthana in Aurangabad, India (FEI 3004995645) after an inspection that ran Mar 6 – Mar 15, 2024. The investigators were Lisa L. Flores and Vaishali J. Patel. Most observations concern production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm failed to establish written procedures for production and process controls designed to assure that…
This inspection in context
Lisa L. Flores
20 documents · 2012–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
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 211.100
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 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Lupin Ltd. 28-1, Midc Industrial Area, Chikalthana?
Lisa L. Flores and Vaishali J. Patel are named on this Form 483, for the inspection of Mar 6 – Mar 15, 2024. 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 Mar 6 – Mar 15, 2024, and the Form 483 is dated March 15, 2024.
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.