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American Hygienics Corporation

⚠️ Moderate Risk

FEI: 3003889562 • Shanghai, Shanghai • CHINA

FEI

FEI Number

3003889562

📍

Location

Shanghai, Shanghai

🇨🇳

Country

CHINA
🏢

Address

439 Huaxulu, Qingpu, Shanghai, Shanghai, China

Moderate Risk

FDA Import Risk Assessment

39.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
2/5/2009
Latest Refusal
4/11/2008
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

722×

NEW VET DR

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.

Refusal History

DateProductViolationsDivision
2/5/2009
63SKY99DENTAL PROTECTANT N.E.C.
72NEW VET DR
Los Angeles District Office (LOS-DO)
4/11/2008
53LF01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
72NEW VET DR
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is American Hygienics Corporation's FDA import refusal history?

American Hygienics Corporation (FEI: 3003889562) has 2 FDA import refusal record(s) in our database, spanning from 4/11/2008 to 2/5/2009.

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. American Hygienics Corporation's FEI number is 3003889562.

What types of violations has American Hygienics Corporation received?

American Hygienics Corporation has been cited for 1 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 American Hygienics Corporation come from?

All FDA import refusal data for American Hygienics Corporation 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.