Home / Facilities / 3005216725

CENOVA AB — FDA Facility Profile

FEI 3005216725

CENOVA AB is an FDA-registered facility (FEI 3005216725) located in MJOLBY Ostergotland, SE. RegDataLab tracks 2 FDA inspections and 1 compliance action at this facility.

Reviewing CENOVA AB 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 CENOVA AB 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

What FDA found at this site

Latest inspection
May 8, 2025: Voluntary Action Indicated (VAI)
Inspections on record
2 (1 VAI, 1 NAI)
Last OAI inspection
None on record
Warning letters
1 listed by FDA for this FEI, latest Feb 25, 2011

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
May 8, 2025Voluntary Action Indicated (VAI)Lack/Inad procedure-Monitoring/Control of Validated Proces (21 CFR 820.75(b))
Nonconforming product control (21 CFR 820.90(a))
DHR content (21 CFR 820.184)
Lack of or inadequate process validation (21 CFR 820.75(a))
Nov 18, 2022No Action Indicated (NAI)No citations listed

Facility details

Company
Cenova AB
Location
MJOLBY Ostergotland (SE)
Source
device

Compliance actions

FDA data resources

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