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Schrofner Cosmetics Gmbh — FDA Facility Profile

FEI 3010632712

Schrofner Cosmetics Gmbh is an FDA-inspected facility (FEI 3010632712) located in Salzburg, AT. RegDataLab tracks 1 FDA inspection and 1 compliance action at this facility.

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What FDA found at this site

Latest inspection
Jul 19, 2017: Official Action Indicated (OAI)
Inspections on record
1 (1 OAI)
Last OAI inspection
Jul 19, 2017
Warning letters
1 listed by FDA for this FEI, latest Dec 20, 2017

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 19, 2017Official Action Indicated (OAI)Authority lacking to review records, investigate errors (21 CFR 211.22(a))
Adequate lab facilities not available (21 CFR 211.22(b))
Approve or reject procedures or specs (21 CFR 211.22(c))
Procedures not in writing, fully followed (21 CFR 211.22(d))
and 28 more

Facility details

Company
Schrofner Cosmetics Gmbh
Location
Salzburg (AT)
Source
inspections

Compliance actions

FDA data resources

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