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Romeo Ficacci SRL — FDA Facility Profile

FEI 2000013035

Romeo Ficacci SRL is an FDA-inspected facility (FEI 2000013035) located in Castel Madama, IT. RegDataLab tracks 2 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Sep 16, 2022: No Action Indicated (NAI)
Inspections on record
2 (1 OAI, 1 NAI)
Last OAI inspection
Feb 8, 2017
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
Sep 16, 2022No Action Indicated (NAI)Storage and Distribution (21 CFR 117.93)
Hazard analysis - Identification of hazard (21 CFR 117.130(a)(1))
Feb 8, 2017Official Action Indicated (OAI)Materials and workmanship (21 CFR 110.40(a))
Scheduled process (21 CFR 114.80(a)(1))
Process filing (21 CFR 108.25(c)(2))

Facility details

Company
Romeo Ficacci SRL
Location
Castel Madama (IT)
Source
inspections

FDA data resources

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