Harlan Johnson & Associates FDA Record

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

Harlan Johnson & Associates has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Harlan Johnson & Associates" is on file.

What these totals cover: FDA records filed under the name "Harlan Johnson & Associates" and its spelling variant "Harlan Johnson And Associates".

Latest inspection
Mar 9, 2020 · VAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections1Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA inspections

1 inspection on Mar 9, 2020.

DateSiteProductClassificationFEI
Mar 9, 2020Burnsville, MNFood/CosmeticsVoluntary Action Indicated (VAI)3013336961
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.

FacilityLocationInspectionsLatest
FEI 3013336961Burnsville, MN1Mar 9, 2020

Harlan Johnson & Associates and the FDA: common questions

Has Harlan Johnson & Associates received an FDA warning letter?

No FDA warning letter addressed to the name "Harlan Johnson & Associates" 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 Harlan Johnson & Associates received an FDA Form 483?

FDA has not published a Form 483 for "Harlan Johnson & Associates" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Harlan Johnson & Associates?

The most recent FDA inspection on file ended Mar 9, 2020 at Burnsville, MN and was classified VAI. FDA has 1 inspection of Harlan Johnson & Associates on file.

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.