Home / Facilities / 3003591774

Bieffe Medital S.P.A. FDA Inspection Record

FEI 3003591774 · Inspections, Form 483s, warning letters and import refusals

Bieffe Medital S.P.A. is an FDA-registered facility (FEI 3003591774) located in SONDALO (SO) Sondrio, IT. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK; STERILIZE. RegDataLab tracks 6 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Nov 17, 2023: Voluntary Action Indicated (VAI)
Inspections on record
6 (5 VAI, 1 NAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Nov 17, 2023Voluntary Action Indicated (VAI)No citations listed
Jun 28, 2019Voluntary Action Indicated (VAI)No citations listed
May 29, 2018Voluntary Action Indicated (VAI)No citations listed
Sep 22, 2015No Action Indicated (NAI)No citations listed
Aug 15, 2013Voluntary Action Indicated (VAI)Design Validation - Risk analysis not performed/inadequate (21 CFR 820.30(g))
Production and Process Change Procedures, lack of or Inad. (21 CFR 820.70(b))
Oct 16, 2009Voluntary Action Indicated (VAI)Design history file (21 CFR 820.30(j))
Investigation of device failures (21 CFR 820.198(c))
Changes to correct/prevent quality problems (21 CFR 820.100(a)(5))
Design Validation - Risk analysis not performed/inadequate (21 CFR 820.30(g))
and 3 more

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

Reviewing Bieffe Medital S.P.A. as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Check this supplier

Or check Bieffe Medital S.P.A. yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.

Get a free API key

Facility details

Company
Bieffe Medital SpA
Location
SONDALO (SO) Sondrio (IT)
Registration Expires
Dec 31, 2026
Operations
ANALYSIS; LABEL; MANUFACTURE; PACK; STERILIZE
Source
both

FDA data resources

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