Lupin Limited Unit 1
Form 483 issued November 26, 2018 · Mandideep, India
- Inspection
- Nov 26, 2018
- Investigators
- Christopher Keating· June P. Page· Pratik S. Upadhyay
- Observations
- 10
- Pages
- 25
- FEI number
- 3002807511
In short: On November 26, 2018, FDA issued a Form 483 with 10 observations to Lupin Limited Unit 1 in Mandideep, India (FEI 3002807511) after an inspection that ran Nov 26, 2018. The investigators were Christopher Keating, June P. Page, Pratik S. Upadhyay and Unnee Ranjan. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 6 of 8 observations.
Most cited: 21 CFR 211.113 (2×) · 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for aseptic process (media fill) simulations, performed in the sterile API manufacturing…
- 02
Cleaning validations arc inadequate for the equipment in…
- 03
Systems for monitoring environmental conditions for Aseptic…
- 04
The cleaning and disinfecting.of the room and equipment used in the processing of aseptic drug products…
This inspection in context
Christopher Keating
13 documents · 2018–2020
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmLupin Limited Unit 1 history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Lupin Limited Unit 1?
FDA listed 10 observations on this Form 483, mostly about production, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Lupin Limited Unit 1?
Christopher Keating, June P. Page, Pratik S. Upadhyay and Unnee Ranjan are named on this Form 483, for the inspection of Nov 26, 2018. Each investigator has a profile showing what they cite most.
When was Lupin Limited Unit 1 inspected by FDA?
The inspection ran Nov 26, 2018, and the Form 483 is dated November 26, 2018.
How do I get the full Form 483 for Lupin Limited Unit 1?
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.