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Reicorp Company

⚠️ Moderate Risk

FEI: 3003710482 • Kwai Chung, New Territories • HONG KONG

FEI

FEI Number

3003710482

📍

Location

Kwai Chung, New Territories

🇭🇰

Country

HONG KONG
🏢

Address

71-75 Container Port Road, , Kwai Chung, New Territories, Hong Kong

Moderate Risk

FDA Import Risk Assessment

25.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
4
Unique Violations
12/2/2009
Latest Refusal
12/2/2009
Earliest Refusal

Score Breakdown

Violation Severity
52.5×40%
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).

30811×

INVDEVICE

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a device for investigational use for which no exemption has been granted as prescribed by Section 520(g)

3331×

LACKS FIRM

The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.

5081×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

DateProductViolationsDivision
12/2/2009
89NHNLAMP, NON-HEATING, FOR ADJUNCTIVE USE IN PAIN THERAPY
118NOT LISTED
3081INVDEVICE
333LACKS FIRM
508NO 510(K)
New England District Office (NWE-DO)

Frequently Asked Questions

What is Reicorp Company's FDA import refusal history?

Reicorp Company (FEI: 3003710482) has 1 FDA import refusal record(s) in our database, spanning from 12/2/2009 to 12/2/2009.

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. Reicorp Company's FEI number is 3003710482.

What types of violations has Reicorp Company received?

Reicorp Company 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 Reicorp Company come from?

All FDA import refusal data for Reicorp Company 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.