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S.D. Biostase

⚠️ Moderate Risk

FEI: 3004048029 • Boynes • FRANCE

FEI

FEI Number

3004048029

📍

Location

Boynes

🇫🇷

Country

FRANCE
🏢

Address

Route De Nancray B.P. 3, , Boynes, , France

Moderate Risk

FDA Import Risk Assessment

35.4
LowModerateHighCritical

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

Statistics

6
Total Refusals
2
Unique Violations
8/23/2004
Latest Refusal
8/23/2004
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
31.3×30%
Recency
0.0×20%
Frequency
60.0×10%
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

1185×

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).

2601×

FALSE

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.

Refusal History

DateProductViolationsDivision
8/23/2004
54YCL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
260FALSE
Los Angeles District Office (LOS-DO)
8/23/2004
66VAL99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
Los Angeles District Office (LOS-DO)
8/23/2004
66VBL99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
Los Angeles District Office (LOS-DO)
8/23/2004
66VBL99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
Los Angeles District Office (LOS-DO)
8/23/2004
66VBQ99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
Los Angeles District Office (LOS-DO)
8/23/2004
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is S.D. Biostase's FDA import refusal history?

S.D. Biostase (FEI: 3004048029) has 6 FDA import refusal record(s) in our database, spanning from 8/23/2004 to 8/23/2004.

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. S.D. Biostase's FEI number is 3004048029.

What types of violations has S.D. Biostase received?

S.D. Biostase 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 S.D. Biostase come from?

All FDA import refusal data for S.D. Biostase 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.