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Rocco Mario

⚠️ High Risk

FEI: 3007201508 • Giffoni Valle Piana, Salerno • ITALY

FEI

FEI Number

3007201508

📍

Location

Giffoni Valle Piana, Salerno

🇮🇹

Country

ITALY
🏢

Address

Via Troisio 3, V.Piana, Giffoni Valle Piana, Salerno, Italy

High Risk

FDA Import Risk Assessment

57.6
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

10
Total Refusals
1
Unique Violations
11/28/2008
Latest Refusal
11/28/2008
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
38.6×30%
Recency
0.0×20%
Frequency
100.0×10%
How is this score calculated?

Proprietary Algorithm

  • 40% Violation Severity — AI-assessed (1-10)
  • 30% Refusal Volume — Logarithmic scale
  • 20% Recency — Decays over 5 years
  • 10% Frequency — Refusals per year

© ImportRefusal.com Original Analysis

Violation Summary

7510×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
11/28/2008
62GDC18DICLOFENAC SODIUM (ANTI-INFLAMMATORY)
75UNAPPROVED
Cincinnati District Office (CIN-DO)
11/28/2008
62GDC18DICLOFENAC SODIUM (ANTI-INFLAMMATORY)
75UNAPPROVED
Cincinnati District Office (CIN-DO)
11/28/2008
56BDC03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
75UNAPPROVED
Cincinnati District Office (CIN-DO)
11/28/2008
61PAC26METFORMIN (ANTI-DIABETIC)
75UNAPPROVED
Cincinnati District Office (CIN-DO)
11/28/2008
61GAC84NORFLOXACIN (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC)
75UNAPPROVED
Cincinnati District Office (CIN-DO)
11/28/2008
66VCA99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Cincinnati District Office (CIN-DO)
11/28/2008
61FCZ37FOSFOMYCIN (ANTI-BACTERIAL) (NOT ANTIBIOTIC)
75UNAPPROVED
Cincinnati District Office (CIN-DO)
11/28/2008
66VCA99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Cincinnati District Office (CIN-DO)
11/28/2008
66VCA99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Cincinnati District Office (CIN-DO)
11/28/2008
56IYC76AZITHROMYCIN (MACAROLIDES)
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Rocco Mario's FDA import refusal history?

Rocco Mario (FEI: 3007201508) has 10 FDA import refusal record(s) in our database, spanning from 11/28/2008 to 11/28/2008.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Rocco Mario's FEI number is 3007201508.

What types of violations has Rocco Mario received?

Rocco Mario has been cited for 1 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about Rocco Mario come from?

All FDA import refusal data for Rocco Mario is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.