Inotiv, Inc.
Form 483 issued October 25, 2025 · West Lafayette, Indiana
- Inspection
- Oct 20 – Oct 24, 2025
- Investigators
- Barbara Wright· Sripal R. Mada
- Observations
- 3
- Pages
- 1
- FEI number
- 1000140135
In short: On October 25, 2025, FDA issued a Form 483 with 3 observations to Inotiv, Inc. in West Lafayette, Indiana (FEI 1000140135) after an inspection that ran Oct 20 – Oct 24, 2025. The investigators were Barbara Wright and Sripal R. Mada. Most observations concern gLP.
At a glance
3 of 3 observations on this 483 concern glp.
What FDA observed
Preview: the opening words of each observation- 01
During the validation of insulin aspart in human serum (validation report #1000-2403020), the effect of lipemia…
- 02
Whole blood stability of insulin aspart was not assessed during method…
- 03
Source records for method validation experiments of long-term stability (validation report #1000-091480-2), dilution integrity, stability in…
This inspection in context
Barbara Wright
6 documents · 2000–2025
Cites 312.60 (general responsibilities of investigators) more than any other section. Most of their documents are for sites in Alabama.
The firmInotiv, Inc. history
The site's inspection history, in date order.
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Questions about this 483
What did FDA find at Inotiv, Inc.?
FDA listed 3 observations on this Form 483, mostly about gLP. The opening words of each observation are shown on this page.
Who inspected Inotiv, Inc.?
Barbara Wright and Sripal R. Mada are named on this Form 483, for the inspection of Oct 20 – Oct 24, 2025. Each investigator has a profile showing what they cite most.
When was Inotiv, Inc. inspected by FDA?
The inspection ran Oct 20 – Oct 24, 2025, and the Form 483 is dated October 25, 2025.
How do I get the full Form 483 for Inotiv, Inc.?
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.