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Wakamoto Pharmaceutial Co Ltd Sagami Ohi Factory

⚠️ Moderate Risk

FEI: 3010410774 • Ashigarakami-gun, Kanagawa-ken • JAPAN

FEI

FEI Number

3010410774

📍

Location

Ashigarakami-gun, Kanagawa-ken

🇯🇵

Country

JAPAN
🏢

Address

378 Kanate Ohimachi Ashigarakamigun, , Ashigarakami-gun, Kanagawa-ken, Japan

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
11/14/2013
Latest Refusal
11/14/2013
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

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).

751×

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
11/14/2013
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Wakamoto Pharmaceutial Co Ltd Sagami Ohi Factory's FDA import refusal history?

Wakamoto Pharmaceutial Co Ltd Sagami Ohi Factory (FEI: 3010410774) has 1 FDA import refusal record(s) in our database, spanning from 11/14/2013 to 11/14/2013.

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. Wakamoto Pharmaceutial Co Ltd Sagami Ohi Factory's FEI number is 3010410774.

What types of violations has Wakamoto Pharmaceutial Co Ltd Sagami Ohi Factory received?

Wakamoto Pharmaceutial Co Ltd Sagami Ohi Factory 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 Wakamoto Pharmaceutial Co Ltd Sagami Ohi Factory come from?

All FDA import refusal data for Wakamoto Pharmaceutial Co Ltd Sagami Ohi Factory 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.