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OVESCO ENDOSCOPY AG — FDA Facility Profile

FEI 3006696607

OVESCO ENDOSCOPY AG is an FDA-registered facility (FEI 3006696607) located in Tuebingen Baden-Wurttemberg, DE. RegDataLab tracks 2 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Jul 13, 2017: No Action Indicated (NAI)
Inspections on record
2 (1 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
Jul 13, 2017No Action Indicated (NAI)No citations listed
Aug 29, 2013Voluntary Action Indicated (VAI)Quality audits - Lack of or inadequate procedures (21 CFR 820.22)
Lack of or inadequate procedures (21 CFR 820.100(a))
Management review - defined interval, sufficient frequency (21 CFR 820.20(c))

Facility details

Company
OVESCO ENDOSCOPY AG
Location
Tuebingen Baden-Wurttemberg (DE)
Source
device

FDA data resources

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