Home / Facilities / 3003610251

Dreve Otoplastik GmbH — FDA Facility Profile

FEI 3003610251

Dreve Otoplastik GmbH is an FDA-registered facility (FEI 3003610251) located in UNNA North Rhine-Westphalia, DE. RegDataLab tracks 2 FDA inspections at this facility.

Reviewing Dreve Otoplastik GmbH 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 Dreve Otoplastik GmbH 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
Sep 7, 2017: Official Action Indicated (OAI)
Inspections on record
2 (2 OAI)
Last OAI inspection
Sep 7, 2017
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Import refusals
3

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
Sep 7, 2017Official Action Indicated (OAI)No citations listed
Aug 21, 2014Official Action Indicated (OAI)Lack of or inadequate procedures (21 CFR 820.100(a))
Document changes, review and approval, communication (21 CFR 820.40(b))
Production processes (21 CFR 820.70(a))

Facility details

Company
Dreve Otoplastik Gmbh
Location
UNNA North Rhine-Westphalia (DE)
Source
device

Import refusals

FDA data resources

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