University Of North Carolina At Chapel Hill (UNC) RDRC FDA Record

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

  • Latest inspection VAI · Sep 16, 2019
  • No warning letters matched by name
Inspections 1 0 OAI
Recalls 0 0 Class I
Warning letters 0 None on file
510(k) clearances 0 None on file

University Of North Carolina At Chapel Hill (UNC) RDRC has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "University Of North Carolina At Chapel Hill (UNC) RDRC" is on file.

What these totals cover: FDA records filed under the name "University Of North Carolina At Chapel Hill (UNC) RDRC".

Latest inspection
Sep 16, 2019 · VAI

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 11, 2026 (checked Nov 15, 2026, unchanged)File dated Nov 10, 2026Current
510(k) clearances0Nov 15, 2026File dated Nov 9, 2026Current
Inspections1Nov 15, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

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Recent FDA inspections

1 inspection on Sep 16, 2019.

DateSiteProductClassificationFEI
Sep 16, 2019Chapel Hill, NCDrugsVoluntary Action Indicated (VAI)3015197472
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 3015197472Chapel Hill, NC1Sep 16, 2019

University Of North Carolina At Chapel Hill (UNC) RDRC and the FDA: common questions

Has University Of North Carolina At Chapel Hill (UNC) RDRC received an FDA warning letter?

No FDA warning letter addressed to the name "University Of North Carolina At Chapel Hill (UNC) RDRC" 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 University Of North Carolina At Chapel Hill (UNC) RDRC received an FDA Form 483?

FDA has not published a Form 483 for "University Of North Carolina At Chapel Hill (UNC) RDRC" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect University Of North Carolina At Chapel Hill (UNC) RDRC?

The most recent FDA inspection on file ended Sep 16, 2019 at Chapel Hill, NC and was classified VAI. FDA has 1 inspection of University Of North Carolina At Chapel Hill (UNC) RDRC on file.

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