LUPIN MANUFACTURING SOLUTIONS LIMITED
Form 483 issued January 17, 2020 · Visakhapatnam, India
- Inspection
- Jan 13 – Jan 17, 2020
- Investigator
- Yasamin Ameri
- Observations
- 5
- Pages
- 4
- FEI number
- 3013127166
In short: On January 17, 2020, FDA issued a Form 483 with 5 observations to LUPIN MANUFACTURING SOLUTIONS LIMITED in Visakhapatnam, Andhra Pradesh (FEI 3013127166) after an inspection that ran Jan 13 – Jan 17, 2020. The investigator was Yasamin Ameri. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Critical process parameters should be controlled and monitored…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Secondaiy reference standards should be appropriately prepared, identified…
- 04
Samples from incoming raw materials should be collected from top, middle, bottom of the raw material…
This inspection in context
Yasamin Ameri
20 documents · 2015–2022
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in India.
The firmLUPIN MANUFACTURING SOLUTIONS LIMITED 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 MANUFACTURING SOLUTIONS LIMITED?
FDA listed 5 observations on this Form 483, mostly about production, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected LUPIN MANUFACTURING SOLUTIONS LIMITED?
Yasamin Ameri is named on this Form 483, for the inspection of Jan 13 – Jan 17, 2020. Each investigator has a profile showing what they cite most.
When was LUPIN MANUFACTURING SOLUTIONS LIMITED inspected by FDA?
The inspection ran Jan 13 – Jan 17, 2020, and the Form 483 is dated January 17, 2020.
How do I get the full Form 483 for LUPIN MANUFACTURING SOLUTIONS 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.