DNA Genotek Inc. FDA Record

Summary

FDA record by year

DNA Genotek Inc.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

DNA Genotek Inc. FDA Warning Letters

1 warning letter on Dec 20, 2013.

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 recalls

3 recall records from Jun 24, 2020 to Feb 18, 2022.

Recent FDA inspections

2 inspections from Sep 20, 2013 to Nov 3, 2016.

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 DNA Genotek Inc.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Dec 20, 2013.

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.

Recent 510(k) clearances

8 510(k) clearances from Dec 2, 2011 to Jun 10, 2026.

DNA Genotek Inc. and the FDA: common questions

Has DNA Genotek Inc. received an FDA warning letter?

Yes. FDA has issued 1 warning letter to DNA Genotek Inc.. The most recent is dated Dec 20, 2013.

Has DNA Genotek Inc. received an FDA Form 483?

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

When did the FDA last inspect DNA Genotek Inc.?

The most recent FDA inspection on file ended Nov 3, 2016 at Kanata, Canada and was classified VAI. FDA has 2 inspections of DNA Genotek Inc. on file, 1 of them classified OAI (official action indicated).

Has DNA Genotek Inc. had an FDA recall?

Yes. DNA Genotek Inc. has 3 FDA recalls on record. The most recent started Feb 18, 2022.