Rusan Pharma Ltd.
Form 483 issued May 3, 2024 · Ankleshwar, India
- Inspection
- Apr 30 – May 3, 2024
- Investigators
- Alan A. Rivera· Angelica M. Hernandez
- Observations
- 3
- Pages
- 3
- FEI number
- 3012065723
In short: On May 3, 2024, FDA issued a Form 483 with 3 observations to Rusan Pharma Ltd. in Ankleshwar, Gujarat (FEI 3012065723) after an inspection that ran Apr 30 – May 3, 2024. The investigators were Alan A. Rivera and Angelica M. Hernandez. 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 scientifically sound and appropriate specifications, sampling plans and test procedures designed…
- 02
The master production record lacks an established time limit detailed in the production instructions to ensure…
- 03
Equipment used in the manufacture of intermediates and API’s should be maintained in a good state…
This inspection in context
Alan A. Rivera
16 documents · 2022–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmRusan Pharma Ltd. 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 Rusan Pharma Ltd.?
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 Rusan Pharma Ltd.?
Alan A. Rivera and Angelica M. Hernandez are named on this Form 483, for the inspection of Apr 30 – May 3, 2024. Each investigator has a profile showing what they cite most.
When was Rusan Pharma Ltd. inspected by FDA?
The inspection ran Apr 30 – May 3, 2024, and the Form 483 is dated May 3, 2024.
How do I get the full Form 483 for Rusan Pharma Ltd.?
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.