RayzeBio, Inc.
Form 483 issued February 24, 2026 · Indianapolis, Indiana
- Inspection
- Jan 28 – Feb 24, 2026
- Investigators
- Muna Algharibeh· Scott D. McGrew
- Observations
- 2
- Pages
- 16
- FEI number
- 3030530655
In short: On February 24, 2026, FDA issued a Form 483 with 2 observations to RayzeBio, Inc. in Indianapolis, Indiana (FEI 3030530655) after an inspection that ran Jan 28 – Feb 24, 2026. The investigators were Muna Algharibeh and Scott D. McGrew.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 04
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Muna Algharibeh
15 documents · 2021–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Indiana.
The firmRayzeBio, Inc. history
The site's inspection history, in date order.
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Questions about this 483
What did FDA find at RayzeBio, Inc.?
FDA listed 2 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected RayzeBio, Inc.?
Muna Algharibeh and Scott D. McGrew are named on this Form 483, for the inspection of Jan 28 – Feb 24, 2026. Each investigator has a profile showing what they cite most.
When was RayzeBio, Inc. inspected by FDA?
The inspection ran Jan 28 – Feb 24, 2026, and the Form 483 is dated February 24, 2026.
How do I get the full Form 483 for RayzeBio, 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.