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Johnson & Johnson (Phils) Inc

⚠️ Moderate Risk

FEI: 1000379767 • Paranaque Metro Manila • PHILIPPINES

FEI

FEI Number

1000379767

📍

Location

Paranaque Metro Manila

🇵🇭
🏢

Address

Edison Rd Bo Ibayo, , Paranaque Metro Manila, , Philippines

Moderate Risk

FDA Import Risk Assessment

44.7
LowModerateHighCritical

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

Statistics

10
Total Refusals
2
Unique Violations
11/1/2012
Latest Refusal
11/20/2003
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
38.6×30%
Recency
0.0×20%
Frequency
11.2×10%
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

759×

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).

1183×

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).

Refusal History

DateProductViolationsDivision
11/1/2012
53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
118NOT LISTED
75UNAPPROVED
Los Angeles District Office (LOS-DO)
11/1/2012
53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
118NOT LISTED
75UNAPPROVED
Los Angeles District Office (LOS-DO)
11/1/2012
62WBY99ASTRINGENT/ANTI-PERSPIRANT N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
11/1/2012
62WBY99ASTRINGENT/ANTI-PERSPIRANT N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
11/1/2012
62WBY99ASTRINGENT/ANTI-PERSPIRANT N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
11/1/2012
62WBY99ASTRINGENT/ANTI-PERSPIRANT N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
11/1/2012
62WBY99ASTRINGENT/ANTI-PERSPIRANT N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
11/1/2012
62WBY99ASTRINGENT/ANTI-PERSPIRANT N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
11/1/2012
62WBY99ASTRINGENT/ANTI-PERSPIRANT N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
11/20/2003
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Johnson & Johnson (Phils) Inc's FDA import refusal history?

Johnson & Johnson (Phils) Inc (FEI: 1000379767) has 10 FDA import refusal record(s) in our database, spanning from 11/20/2003 to 11/1/2012.

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 (Phils) Inc's FEI number is 1000379767.

What types of violations has Johnson & Johnson (Phils) Inc received?

Johnson & Johnson (Phils) Inc 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 (Phils) Inc come from?

All FDA import refusal data for Johnson & Johnson (Phils) Inc 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.