Biogenex Laboratories, Inc.

Form 483

Fremont, California, United StatesFEI 2936532Issued October 06, 2025

View FDA's Record for This Firm

Source: FDA inspection record. Confirmed against FDA's published inspection data for this establishment and inspection date. FDA has published the inspection and what it cited, but not the form itself, which usually takes six to twelve months. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 2936532.

Observations3

Issue DateOctober 06, 2025

StatusNo Warning Letter

Related Inspections5

Establishment Details

Firm: Biogenex Laboratories, Inc.
Location: Fremont, California, United States
FEI Number: 2936532
Product Type: Devices
Issue Date: October 06, 2025
Country: United States

Inspection History, 2012 to 2025

NAI2

VAI3

NAI means No Action Indicated. VAI means Voluntary Action Indicated.

Act on This Form 483

FDA Inspection ReadinessSee how your operations would hold up to the same scrutiny.CAPA & InvestigationsScore how you would investigate and close findings like these.Talk to a SpecialistWalk through these observations with a ComplianceQuest expert.

Biogenex Laboratories, Inc. FDA Form 483, Fremont, California, October 6, 2025