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Bio-Scientific Ind. De Cosm.Ltda

⚠️ High Risk

FEI: 3008853148 • Sao Paulo • BRAZIL

FEI

FEI Number

3008853148

📍

Location

Sao Paulo

🇧🇷

Country

BRAZIL
🏢

Address

Av. Albert Einstein, 80-B1.Bgalpao 4, , Sao Paulo, , Brazil

High Risk

FDA Import Risk Assessment

50.0
LowModerateHighCritical

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

Statistics

20
Total Refusals
6
Unique Violations
10/17/2011
Latest Refusal
10/17/2011
Earliest Refusal

Score Breakdown

Violation Severity
63.3×40%
Refusal Volume
49.0×30%
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

11812×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

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).

4725×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

1783×

COL ADDED

The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).

2233×

FALSE

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.

3303×

UNSAFE COL

The article appears to be a color additive for the purposes of coloring only in or on drugs or devices, and is unsafe within the meaning of Section 721(a).

Refusal History

DateProductViolationsDivision
10/17/2011
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
472NO ENGLISH
Division of Southeast Imports (DSEI)
10/17/2011
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
472NO ENGLISH
Division of Southeast Imports (DSEI)
10/17/2011
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
472NO ENGLISH
Division of Southeast Imports (DSEI)
10/17/2011
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
330UNSAFE COL
Division of Southeast Imports (DSEI)
10/17/2011
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
223FALSE
Division of Southeast Imports (DSEI)
10/17/2011
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
178COL ADDED
Division of Southeast Imports (DSEI)
10/17/2011
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
178COL ADDED
Division of Southeast Imports (DSEI)
10/17/2011
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
178COL ADDED
Division of Southeast Imports (DSEI)
10/17/2011
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
472NO ENGLISH
75UNAPPROVED
Division of Southeast Imports (DSEI)
10/17/2011
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
472NO ENGLISH
75UNAPPROVED
Division of Southeast Imports (DSEI)
10/17/2011
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
330UNSAFE COL
75UNAPPROVED
Division of Southeast Imports (DSEI)
10/17/2011
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
330UNSAFE COL
75UNAPPROVED
Division of Southeast Imports (DSEI)
10/17/2011
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
223FALSE
75UNAPPROVED
Division of Southeast Imports (DSEI)
10/17/2011
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
223FALSE
75UNAPPROVED
Division of Southeast Imports (DSEI)
10/17/2011
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
Division of Southeast Imports (DSEI)
10/17/2011
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
Division of Southeast Imports (DSEI)
10/17/2011
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
Division of Southeast Imports (DSEI)
10/17/2011
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
Division of Southeast Imports (DSEI)
10/17/2011
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
Division of Southeast Imports (DSEI)
10/17/2011
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Bio-Scientific Ind. De Cosm.Ltda's FDA import refusal history?

Bio-Scientific Ind. De Cosm.Ltda (FEI: 3008853148) has 20 FDA import refusal record(s) in our database, spanning from 10/17/2011 to 10/17/2011.

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. Bio-Scientific Ind. De Cosm.Ltda's FEI number is 3008853148.

What types of violations has Bio-Scientific Ind. De Cosm.Ltda received?

Bio-Scientific Ind. De Cosm.Ltda has been cited for 6 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 Bio-Scientific Ind. De Cosm.Ltda come from?

All FDA import refusal data for Bio-Scientific Ind. De Cosm.Ltda 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.