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BioEclipse Therapeutics, Inc. FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

BioEclipse Therapeutics, Inc. has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "BioEclipse Therapeutics, Inc." is on file. FDA has published 1 Form 483 for BioEclipse Therapeutics, Inc..

What these totals cover: FDA records filed under the name "BioEclipse Therapeutics, Inc." and its spelling variant "Bioeclipse Therapeutics".

Latest inspection: Mar 25, 2025 · VAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	1	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

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BioEclipse Therapeutics, Inc. Form 483s

1 Form 483 published by FDA.

Date	Document	FEI
Mar 25, 2025 · Document on fda.gov	483	3033709371

A Form 483 lists the observations FDA investigators made at the end of an inspection. FDA publishes some Form 483s in its reading room, and each date links to that document. Read the observations with the FDA 483 search.

Recent FDA inspections

1 inspection on Mar 25, 2025.

Date	Site	Product	Classification	FEI
Mar 25, 2025	Mountain View, CA	Biologics	Voluntary Action Indicated (VAI)	3033709371

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3033709371	Mountain View, CA	1	Mar 25, 2025

BioEclipse Therapeutics, Inc. and the FDA: common questions

Has BioEclipse Therapeutics, Inc. received an FDA warning letter?

No FDA warning letter addressed to the name "BioEclipse Therapeutics, Inc." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has BioEclipse Therapeutics, Inc. received an FDA Form 483?

FDA has published 1 Form 483 for BioEclipse Therapeutics, Inc. in its reading room, the most recent dated Mar 25, 2025. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect BioEclipse Therapeutics, Inc.?

The most recent FDA inspection on file ended Mar 25, 2025 at Mountain View, CA and was classified VAI. FDA has 1 inspection of BioEclipse Therapeutics, Inc. on file.

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