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A.H.A INTERNATIONAL CO.,LTD

⚠️ Moderate Risk

FEI: 3003806572 • Hefei, Anhui • CHINA

FEI

FEI Number

3003806572

📍

Location

Hefei, Anhui

🇨🇳

Country

CHINA
🏢

Address

Jinan Mansion, 306 Tunxilu, Hefei, Anhui, China

Moderate Risk

FDA Import Risk Assessment

37.6
LowModerateHighCritical

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

Statistics

5
Total Refusals
4
Unique Violations
4/14/2008
Latest Refusal
1/16/2003
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
9.5×10%
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

1183×

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).

162×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

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).

2381×

UNSAFE ADD

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.

Refusal History

DateProductViolationsDivision
4/14/2008
45KG01MONOSODIUM GLUTAMATE (MSG) (FOOD ADDITIVES FOR HUMAN USE)
238UNSAFE ADD
Atlanta District Office (ATL-DO)
12/15/2006
61JAS08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC)
118NOT LISTED
16DIRECTIONS
New York District Office (NYK-DO)
12/15/2006
62GAS41IBUPROFEN (ANTI-INFLAMMATORY)
118NOT LISTED
16DIRECTIONS
New York District Office (NYK-DO)
12/29/2003
65JCY31PROGESTERONE (PROGESTIN)
118NOT LISTED
75UNAPPROVED
Los Angeles District Office (LOS-DO)
1/16/2003
54FBH99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is A.H.A INTERNATIONAL CO.,LTD's FDA import refusal history?

A.H.A INTERNATIONAL CO.,LTD (FEI: 3003806572) has 5 FDA import refusal record(s) in our database, spanning from 1/16/2003 to 4/14/2008.

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. A.H.A INTERNATIONAL CO.,LTD's FEI number is 3003806572.

What types of violations has A.H.A INTERNATIONAL CO.,LTD received?

A.H.A INTERNATIONAL CO.,LTD 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 A.H.A INTERNATIONAL CO.,LTD come from?

All FDA import refusal data for A.H.A INTERNATIONAL CO.,LTD 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.