ANCOROTTI COSMETICS SPA FDA Inspection Record

FEI 3007931801 · Inspections, Form 483s, warning letters and import refusals

ANCOROTTI COSMETICS SPA is an FDA-registered facility (FEI 3007931801) located in Crema, IT. Registered operations: MANUFACTURE. RegDataLab tracks 1 FDA inspection at this facility.

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What FDA found at this site

Latest inspection
Sep 19, 2019: Voluntary Action Indicated (VAI)
Inspections on record
1 (1 VAI)
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
Import refusals
7

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 19, 2019Voluntary Action Indicated (VAI)Procedures not in writing, fully followed (21 CFR 211.22(d))
Written procedures not established/followed (21 CFR 211.67(b))
SOPs not followed / documented (21 CFR 211.100(b))
Label storage access limited to authorized personnel (21 CFR 211.122(d))
and 3 more

Facility details

Company
Ancorotti Cosmetics Srl
Location
Crema (IT)
Registration Expires
Dec 31, 2027
Operations
MANUFACTURE
Source
decrs

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