R.L.Fine Chem Private Limited
Form 483 issued April 14, 2023 · Bengaluru, India
- Inspection
- Apr 10 – Apr 14, 2023
- Investigator
- Vivin George
- Observations
- 2
- Pages
- 2
- FEI number
- 3013140488
In short: On April 14, 2023, FDA issued a Form 483 with 2 observations to R.L.Fine Chem Private Limited in Bengaluru, Karnataka (FEI 3013140488) after an inspection that ran Apr 10 – Apr 14, 2023. The investigator was Vivin George. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 2 of 2 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to adequately…
- 02
There is a failure to explain any…
This inspection in context
Vivin George
20 documents · 2019–2025
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in New York.
The firmR.L.Fine Chem Private Limited history
The site's inspection history, in date order.
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 R.L.Fine Chem Private Limited?
FDA listed 2 observations on this Form 483, mostly about quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected R.L.Fine Chem Private Limited?
Vivin George is named on this Form 483, for the inspection of Apr 10 – Apr 14, 2023. Each investigator has a profile showing what they cite most.
When was R.L.Fine Chem Private Limited inspected by FDA?
The inspection ran Apr 10 – Apr 14, 2023, and the Form 483 is dated April 14, 2023.
How do I get the full Form 483 for R.L.Fine Chem Private 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.