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Johnson & Johnson Sa

⚠️ Moderate Risk

FEI: 3011697188 • Madrid, Madrid • SPAIN

FEI

FEI Number

3011697188

📍

Location

Madrid, Madrid

🇪🇸

Country

SPAIN
🏢

Address

Calle Gabriela Mistral 16, , Madrid, Madrid, Spain

Moderate Risk

FDA Import Risk Assessment

41.4
LowModerateHighCritical

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

Statistics

6
Total Refusals
2
Unique Violations
10/2/2015
Latest Refusal
10/2/2015
Earliest Refusal

Score Breakdown

Violation Severity
65.0×40%
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

4713×

CSTIC LBLG

The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.

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).

Refusal History

DateProductViolationsDivision
10/2/2015
53JA02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
471CSTIC LBLG
Florida District Office (FLA-DO)
10/2/2015
53JA02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
471CSTIC LBLG
Florida District Office (FLA-DO)
10/2/2015
53JA02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
471CSTIC LBLG
Florida District Office (FLA-DO)
10/2/2015
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Florida District Office (FLA-DO)
10/2/2015
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Florida District Office (FLA-DO)
10/2/2015
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Johnson & Johnson Sa's FDA import refusal history?

Johnson & Johnson Sa (FEI: 3011697188) has 6 FDA import refusal record(s) in our database, spanning from 10/2/2015 to 10/2/2015.

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. Johnson & Johnson Sa's FEI number is 3011697188.

What types of violations has Johnson & Johnson Sa received?

Johnson & Johnson Sa 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 Johnson & Johnson Sa come from?

All FDA import refusal data for Johnson & Johnson Sa 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.