Rubicon Research Limited
Form 483 issued January 27, 2023 · Satara, India
- Inspection
- Jan 23 – Jan 27, 2023
- Investigator
- Michael A. Charles
- Observations
- 3
- Pages
- 3
- FEI number
- 3012953979
In short: On January 27, 2023, FDA issued a Form 483 with 3 observations to Rubicon Research Limited in Satara, Maharashtra (FEI 3012953979) after an inspection that ran Jan 23 – Jan 27, 2023. The investigator was Michael A. Charles. Most observations concern laboratory controls and production.
At a glance
Laboratory controls and production account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate standards, sampling plans and…
- 02
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 03
The plumbing system contains defects that could contribute to the…
This inspection in context
Michael A. Charles
29 documents · 2013–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Colorado.
The firmRubicon Research Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Rubicon Research Limited?
FDA listed 3 observations on this Form 483, mostly about laboratory controls, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Rubicon Research Limited?
Michael A. Charles is named on this Form 483, for the inspection of Jan 23 – Jan 27, 2023. Each investigator has a profile showing what they cite most.
When was Rubicon Research Limited inspected by FDA?
The inspection ran Jan 23 – Jan 27, 2023, and the Form 483 is dated January 27, 2023.
How do I get the full Form 483 for Rubicon Research 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.