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Bionetek Corporation FDA Record

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

Latest inspection VAI · Apr 10, 2012
Last warning letter 2011

Inspections 2

1 OAI

Recalls 0 0 Class I

Warning letters 1 Latest Apr 18, 2011

510(k) clearances 0 None on file

Bionetek Corporation has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Bionetek Corporation, the most recent on Apr 18, 2011.

What these totals cover: FDA records filed under the name "Bionetek Corporation".

Latest inspection: Apr 10, 2012 · 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	2	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

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Bionetek Corporation FDA Warning Letters

1 warning letter on Apr 18, 2011.

Issued	Subject	Issuing office	Close-out letter
Apr 18, 2011 · Record page

A warning letter is FDA's formal notice that a company has violated FDA requirements. Each date links to the letter on fda.gov where FDA has it online. Search the text of every letter with the FDA warning letter search.

Recent FDA inspections

2 inspections from Jan 27, 2011 to Apr 10, 2012.

Date	Site	Product	Classification	FEI
Apr 10, 2012	El Monte, CA	Devices	Voluntary Action Indicated (VAI)	3008740613
Jan 27, 2011	El Monte, CA	Devices	Official Action Indicated (OAI)	3008740613

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.

Compliance Actions

FDA's compliance actions data lists 1 compliance action under Bionetek Corporation: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Apr 18, 2011.

The warning letters in this data are listed above, together with the letters FDA posts online; a letter found in both is shown once. Other actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3008740613	El Monte, CA	2	Apr 10, 2012

Bionetek Corporation and the FDA: common questions

Has Bionetek Corporation received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Bionetek Corporation. The most recent is dated Apr 18, 2011.

Has Bionetek Corporation received an FDA Form 483?

FDA has not published a Form 483 for "Bionetek Corporation" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Bionetek Corporation?

The most recent FDA inspection on file ended Apr 10, 2012 at El Monte, CA and was classified VAI. FDA has 2 inspections of Bionetek Corporation on file, 1 of them classified OAI (official action indicated).

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