Cliantha Research Limited
Form 483 issued April 17, 2026 · Ahmedabad, India
- Inspection
- Apr 13 – Apr 17, 2026
- Investigators
- Anna M. Brannen· Kara A. Scheibner· Koffi A. Amegadje
- Observations
- 6
- Pages
- 5
- FEI number
- 3017682080
In short: On April 17, 2026, FDA issued a Form 483 with 6 observations to Cliantha Research Limited in Ahmedabad, Gujarat (FEI 3017682080) after an inspection that ran Apr 13 – Apr 17, 2026. The investigators were Anna M. Brannen, Kara A. Scheibner, Koffi A. Amegadje and Miguel A. Martinez. Most observations concern clinical (BIMO).
At a glance
Observations span 1 system, led by clinical (bimo).
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 0221 CFR 320.38
The firm did not maintain all source…
- 03
The fimi was unable to account for missing sample volume in samples…
- 04
The film reported inaccurate data in the bioanalytical report…
This inspection in context
Anna M. Brannen
2 documents · 2009–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmCliantha Research Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 50.20
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cliantha Research Limited?
FDA listed 6 observations on this Form 483, mostly about clinical (BIMO). The opening words of each observation are shown on this page.
Who inspected Cliantha Research Limited?
Anna M. Brannen, Kara A. Scheibner, Koffi A. Amegadje and Miguel A. Martinez are named on this Form 483, for the inspection of Apr 13 – Apr 17, 2026. Each investigator has a profile showing what they cite most.
When was Cliantha Research Limited inspected by FDA?
The inspection ran Apr 13 – Apr 17, 2026, and the Form 483 is dated April 17, 2026.
How do I get the full Form 483 for Cliantha 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.