Device establishmentActive, RegisteredFDA warning letter on file
AGENA BIOSCIENCE INCORPORATED
AGENA BIOSCIENCE INCORPORATED is an FDA-registered device establishment (FEI 3010962166) located in San Diego, California. The facility is active, registered. Its most recent FDA inspection on record (2023-06-13) was classified NAI. FDA has issued 1 warning letter(s) to this facility.
FDA warning letter
A warning letter is FDA's formal notice of significant violations that require prompt correction. It can hold up product approvals, trigger import alerts, and put supply agreements at risk until the issues are resolved and FDA closes it out.
Establishment record
Inspection history
Jun 13, 2023 · Official Action Indicated (OAI)
Mar 20, 2019 · No Action Indicated (NAI)
Mar 12, 2015 · No Action Indicated (NAI)
FDA record timeline
Combined chronology of the public records shown on this page. FDA coverage varies by dataset and year.
Questions
Is AGENA BIOSCIENCE INCORPORATED registered with the FDA?
Yes. AGENA BIOSCIENCE INCORPORATED is an FDA-registered device establishment (FEI 3010962166) in San Diego, California. Its current registration status is Active, Registered.
Has AGENA BIOSCIENCE INCORPORATED received an FDA warning letter?
Yes. FDA issued a warning letter to AGENA BIOSCIENCE INCORPORATED; the most recent is dated Mar 21, 2024 (Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)).
What does AGENA BIOSCIENCE INCORPORATED do?
AGENA BIOSCIENCE INCORPORATED's FDA-registered operations are: Pathology, Manufacture Medical Device, Clinical Chemistry.
Related facilities
Source: FDA public data · status as of 2026-08-22