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MEDINOL LTD. — FDA Facility Profile

FEI 3003182398

MEDINOL LTD. is an FDA-registered facility (FEI 3003182398) located in Jerusalem, IL. RegDataLab tracks 2 FDA inspections and 1 compliance action at this facility.

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What FDA found at this site

Latest inspection
Aug 24, 2017: No Action Indicated (NAI)
Inspections on record
2 (1 VAI, 1 NAI)
Last OAI inspection
None on record
Warning letters
1 listed by FDA for this FEI, latest Jul 29, 2014

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
Aug 24, 2017No Action Indicated (NAI)No citations listed
Mar 27, 2014Voluntary Action Indicated (VAI)Quality audits - Lack of or inadequate procedures (21 CFR 820.22)
Lack of or inadequate receiving acceptance procedures (21 CFR 820.80(b))
Lack of or inadequate procedures (21 CFR 820.100(a))
Management review - Lack of or inadequate procedures (21 CFR 820.20(c))
and 3 more

Facility details

Company
Medinol Ltd.
Location
Jerusalem (IL)
Source
device

Compliance actions

FDA data resources

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