Prince Medical Industry SUARL FDA Record

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

  • Latest inspection NAI · Dec 15, 2022
  • Last warning letter 2012
Inspections 2 1 OAI
Recalls 0 0 Class I
Warning letters 1 Latest Aug 3, 2012
510(k) clearances 0 None on file

Prince Medical Industry SUARL has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Prince Medical Industry SUARL, the most recent on Aug 3, 2012.

What these totals cover: FDA records filed under the name "Prince Medical Industry SUARL".

Latest inspection
Dec 15, 2022 · NAI

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
Inspections2Nov 15, 2026Newest record Nov 5, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

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Prince Medical Industry SUARL FDA Warning Letters

1 warning letter on Aug 3, 2012.

IssuedSubjectIssuing officeClose-out letter
Aug 3, 2012 · 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 Apr 2, 2012 to Dec 15, 2022.

DateSiteProductClassificationFEI
Dec 15, 2022Bizerte, TunisiaDevicesNo Action Indicated (NAI)3009346747
Apr 2, 2012Bizerte, TunisiaDevicesOfficial Action Indicated (OAI)3009346747
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 Prince Medical Industry SUARL: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Aug 3, 2012.

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.

FacilityLocationInspectionsLatest
FEI 3009346747Bizerte, Tunisia2Dec 15, 2022

Prince Medical Industry SUARL and the FDA: common questions

Has Prince Medical Industry SUARL received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Prince Medical Industry SUARL. The most recent is dated Aug 3, 2012.

Has Prince Medical Industry SUARL received an FDA Form 483?

FDA has not published a Form 483 for "Prince Medical Industry SUARL" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Prince Medical Industry SUARL?

The most recent FDA inspection on file ended Dec 15, 2022 at Bizerte, Tunisia and was classified NAI. FDA has 2 inspections of Prince Medical Industry SUARL on file, 1 of them classified OAI (official action indicated).

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