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Skin Rebirth

⚠️ High Risk

FEI: 3003245145 • Empuriabram • SPAIN

FEI

FEI Number

3003245145

📍

Location

Empuriabram

🇪🇸

Country

SPAIN
🏢

Address

Migjorn 9, , Empuriabram, , Spain

High Risk

FDA Import Risk Assessment

57.2
LowModerateHighCritical

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

Statistics

22
Total Refusals
2
Unique Violations
10/24/2005
Latest Refusal
8/5/2003
Earliest Refusal

Score Breakdown

Violation Severity
80.5×40%
Refusal Volume
50.4×30%
Recency
0.0×20%
Frequency
99.0×10%
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

2721×

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).

751×

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
10/24/2005
66VCK99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Cincinnati District Office (CIN-DO)
10/24/2005
66VCK99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Cincinnati District Office (CIN-DO)
10/24/2005
66VCK99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Cincinnati District Office (CIN-DO)
10/24/2005
66VCK99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Cincinnati District Office (CIN-DO)
10/24/2005
66VCK99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Cincinnati District Office (CIN-DO)
10/24/2005
66VCK99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Cincinnati District Office (CIN-DO)
10/24/2005
66VCK99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Cincinnati District Office (CIN-DO)
10/24/2005
66VCK99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Cincinnati District Office (CIN-DO)
10/24/2005
66VCK99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Cincinnati District Office (CIN-DO)
10/24/2005
66VCK99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Cincinnati District Office (CIN-DO)
10/24/2005
66VCK99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Cincinnati District Office (CIN-DO)
10/24/2005
66VCK99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Cincinnati District Office (CIN-DO)
10/24/2005
66VCK99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Cincinnati District Office (CIN-DO)
10/24/2005
66VCK99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Cincinnati District Office (CIN-DO)
10/24/2005
66VCK99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Cincinnati District Office (CIN-DO)
10/24/2005
66VCK99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Cincinnati District Office (CIN-DO)
10/24/2005
66VCK99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Cincinnati District Office (CIN-DO)
10/24/2005
66VCK99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Cincinnati District Office (CIN-DO)
10/24/2005
66VCK99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Cincinnati District Office (CIN-DO)
10/24/2005
66VCK99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Cincinnati District Office (CIN-DO)
10/24/2005
66VCK99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Cincinnati District Office (CIN-DO)
8/5/2003
60QCS46PROCAINE HCL (ANESTHETIC)
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Skin Rebirth's FDA import refusal history?

Skin Rebirth (FEI: 3003245145) has 22 FDA import refusal record(s) in our database, spanning from 8/5/2003 to 10/24/2005.

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. Skin Rebirth's FEI number is 3003245145.

What types of violations has Skin Rebirth received?

Skin Rebirth 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 Skin Rebirth come from?

All FDA import refusal data for Skin Rebirth 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.