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Ups - Rts Trk 121796lgzym

⚠️ Moderate Risk

FEI: 3007495919 • Monzamonza • ITALY

FEI

FEI Number

3007495919

📍

Location

Monzamonza

🇮🇹

Country

ITALY
🏢

Address

Nastrificio Carlo Tagliabue Sncvia, , Monzamonza, , Italy

Moderate Risk

FDA Import Risk Assessment

44.1
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

3
Total Refusals
2
Unique Violations
4/28/2009
Latest Refusal
4/28/2009
Earliest Refusal

Score Breakdown

Violation Severity
86.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

753×

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).

272×

DRUG GMPS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).

Refusal History

DateProductViolationsDivision
4/28/2009
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Cincinnati District Office (CIN-DO)
4/28/2009
66VCK99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
75UNAPPROVED
Cincinnati District Office (CIN-DO)
4/28/2009
66VCK99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Ups - Rts Trk 121796lgzym's FDA import refusal history?

Ups - Rts Trk 121796lgzym (FEI: 3007495919) has 3 FDA import refusal record(s) in our database, spanning from 4/28/2009 to 4/28/2009.

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. Ups - Rts Trk 121796lgzym's FEI number is 3007495919.

What types of violations has Ups - Rts Trk 121796lgzym received?

Ups - Rts Trk 121796lgzym has been cited for 2 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 Ups - Rts Trk 121796lgzym come from?

All FDA import refusal data for Ups - Rts Trk 121796lgzym 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.