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Kenneth Salazar

⚠️ Moderate Risk

FEI: 3010690956 • Tagaytay • PHILIPPINES

FEI

FEI Number

3010690956

📍

Location

Tagaytay

🇵🇭
🏢

Address

Purok 91 Barangay Mag-Asawang Ilat, , Tagaytay, , Philippines

Moderate Risk

FDA Import Risk Assessment

48.5
LowModerateHighCritical

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

Statistics

7
Total Refusals
3
Unique Violations
9/25/2014
Latest Refusal
3/26/2014
Earliest Refusal

Score Breakdown

Violation Severity
78.8×40%
Refusal Volume
33.5×30%
Recency
0.0×20%
Frequency
70.0×10%
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

756×

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).

1181×

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).

4731×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

Refusal History

DateProductViolationsDivision
9/25/2014
53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
75UNAPPROVED
Los Angeles District Office (LOS-DO)
9/25/2014
53JD02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
75UNAPPROVED
Los Angeles District Office (LOS-DO)
9/25/2014
53JF01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
75UNAPPROVED
Los Angeles District Office (LOS-DO)
9/25/2014
53JF01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
75UNAPPROVED
Los Angeles District Office (LOS-DO)
9/25/2014
53JF01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
75UNAPPROVED
Los Angeles District Office (LOS-DO)
9/25/2014
54ACR99VITAMIN, N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
3/26/2014
62W99ASTRINGENT/ANTI-PERSPIRANT N.E.C.
118NOT LISTED
473LABELING
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Kenneth Salazar's FDA import refusal history?

Kenneth Salazar (FEI: 3010690956) has 7 FDA import refusal record(s) in our database, spanning from 3/26/2014 to 9/25/2014.

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. Kenneth Salazar's FEI number is 3010690956.

What types of violations has Kenneth Salazar received?

Kenneth Salazar has been cited for 3 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 Kenneth Salazar come from?

All FDA import refusal data for Kenneth Salazar 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.