ImportRefusal LogoImportRefusal

Northridge Import And Export, Inc.

⚠️ Moderate Risk

FEI: 3004011755 • Mandaluyong • PHILIPPINES

FEI

FEI Number

3004011755

📍

Location

Mandaluyong

🇵🇭
🏢

Address

46 Calbayog Street, , Mandaluyong, , Philippines

Moderate Risk

FDA Import Risk Assessment

44.8
LowModerateHighCritical

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

Statistics

11
Total Refusals
4
Unique Violations
7/14/2003
Latest Refusal
7/14/2003
Earliest Refusal

Score Breakdown

Violation Severity
56.9×40%
Refusal Volume
40.0×30%
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

1188×

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).

3412×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

752×

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).

2491×

FILTHY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.

Refusal History

DateProductViolationsDivision
7/14/2003
85HHDPAD, MENSTRUAL, UNSCENTED
341REGISTERED
Los Angeles District Office (LOS-DO)
7/14/2003
85HHDPAD, MENSTRUAL, UNSCENTED
341REGISTERED
Los Angeles District Office (LOS-DO)
7/14/2003
16YCP09FISH SAUCE, FISHERY PRODUCTS, N.E.C.
249FILTHY
Los Angeles District Office (LOS-DO)
7/14/2003
66VBL99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
Los Angeles District Office (LOS-DO)
7/14/2003
66VBL99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
Los Angeles District Office (LOS-DO)
7/14/2003
66VBL99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
Los Angeles District Office (LOS-DO)
7/14/2003
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
Los Angeles District Office (LOS-DO)
7/14/2003
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
Los Angeles District Office (LOS-DO)
7/14/2003
62MAJ08MENTHOL (ANTI-PRURITIC)
118NOT LISTED
Los Angeles District Office (LOS-DO)
7/14/2003
62MBL08MENTHOL (ANTI-PRURITIC)
118NOT LISTED
Los Angeles District Office (LOS-DO)
7/14/2003
62MBL08MENTHOL (ANTI-PRURITIC)
118NOT LISTED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Northridge Import And Export, Inc.'s FDA import refusal history?

Northridge Import And Export, Inc. (FEI: 3004011755) has 11 FDA import refusal record(s) in our database, spanning from 7/14/2003 to 7/14/2003.

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. Northridge Import And Export, Inc.'s FEI number is 3004011755.

What types of violations has Northridge Import And Export, Inc. received?

Northridge Import And Export, Inc. has been cited for 4 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 Northridge Import And Export, Inc. come from?

All FDA import refusal data for Northridge Import And Export, 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.