Bieffe Medital SpA FDA Record

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

Bieffe Medital SpA has 0 FDA recalls, 11 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Bieffe Medital SpA" is on file.

What these totals cover: FDA records filed under the name "Bieffe Medital SpA" and its spelling variant "Bieffe Medital".

Latest inspection
Apr 11, 2025 · VAI

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
Inspections11Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

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

Bieffe Medital SpA: FDA inspections per year 2017: 0 inspections020172018: 1 inspections120182019: 2 inspections220192020: 0 inspections020202021: 1 inspections120212022: 0 inspections020222023: 1 inspections120232024: 0 inspections020242025: 1 inspections120252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202510000
202400000
202310000
202200000
202110000
202000000
201920000
201810000
201700000

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.

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Recent FDA inspections

11 inspections from Oct 16, 2009 to Apr 11, 2025.

DateSiteProductClassificationFEI
Apr 11, 2025Sabinanigo, SpainDrugsVoluntary Action Indicated (VAI)3005164365
Nov 17, 2023Sondalo, ItalyDrugsVoluntary Action Indicated (VAI)3003591774
Apr 22, 2021Sabinanigo, SpainDrugsVoluntary Action Indicated (VAI)3005164365
Aug 8, 2019Grosotto, ItalyDrugsNo Action Indicated (NAI)1000579854
Jun 28, 2019Sondalo, ItalyDrugsVoluntary Action Indicated (VAI)3003591774
May 29, 2018Sondalo, ItalyDrugsVoluntary Action Indicated (VAI)3003591774
Jul 20, 2016Sabinanigo, SpainDrugsNo Action Indicated (NAI)3005164365
Sep 22, 2015Sondalo, ItalyDrugsNo Action Indicated (NAI)3003591774
Feb 23, 2014Sabinanigo, SpainDrugsVoluntary Action Indicated (VAI)3005164365
Aug 15, 2013Sondalo, ItalyDrugsVoluntary Action Indicated (VAI)3003591774
Oct 16, 2009Sondalo, ItalyDevicesVoluntary Action Indicated (VAI)3003591774
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

3 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3005164365Sabinanigo, Spain4Apr 11, 2025
FEI 3003591774Sondalo, Italy6Nov 17, 2023
FEI 1000579854Grosotto, Italy1Aug 8, 2019

Bieffe Medital SpA and the FDA: common questions

Has Bieffe Medital SpA received an FDA warning letter?

No FDA warning letter addressed to the name "Bieffe Medital SpA" 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 Bieffe Medital SpA received an FDA Form 483?

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

When did the FDA last inspect Bieffe Medital SpA?

The most recent FDA inspection on file ended Apr 11, 2025 at Sabinanigo, Spain and was classified VAI. FDA has 11 inspections of Bieffe Medital SpA on file.

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