BioEclipse Therapeutics, Inc.
Form 483 issued March 25, 2025
- Inspection
- Mar 18 – Mar 25, 2025
- Investigator
- Kristin M. Abaonza
- Observations
- 1
- Pages
- 3
- FEI number
- 3033709371
In short: On March 25, 2025, FDA issued a Form 483 with 1 observation to BioEclipse Therapeutics, Inc. (FEI 3033709371) after an inspection that ran Mar 18 – Mar 25, 2025. The investigator was Kristin M. Abaonza. Most observations concern clinical (BIMO); the most-cited regulation is 21 CFR 312.50 (general responsibilities of sponsors).
At a glance
1 of 1 observations on this 483 concern clinical (bimo).
Most cited: 21 CFR 312.50 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Failure to ensure proper monitoring of the study and ensure the study is conducted in accordance…
This inspection in context
Kristin M. Abaonza
12 documents · 2015–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in California.
The firmBioEclipse Therapeutics, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 312.50
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at BioEclipse Therapeutics, Inc.?
FDA listed 1 observation on this Form 483, mostly about clinical (BIMO). The most-cited regulation is 21 CFR 312.50 (general responsibilities of sponsors). The opening words of each observation are shown on this page.
Who inspected BioEclipse Therapeutics, Inc.?
Kristin M. Abaonza is named on this Form 483, for the inspection of Mar 18 – Mar 25, 2025. Each investigator has a profile showing what they cite most.
When was BioEclipse Therapeutics, Inc. inspected by FDA?
The inspection ran Mar 18 – Mar 25, 2025, and the Form 483 is dated March 25, 2025.
How do I get the full Form 483 for BioEclipse Therapeutics, 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.