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Acmt International ( Hk 0 Ltd.

⚠️ Moderate Risk

FEI: 3010280663 • Hong Kong • HONG KONG

FEI

FEI Number

3010280663

📍

Location

Hong Kong

🇭🇰

Country

HONG KONG
🏢

Address

Unit D-E , 15f,Block A, Marvel Ind.Bldg, , Hong Kong, , Hong Kong

Moderate Risk

FDA Import Risk Assessment

43.4
LowModerateHighCritical

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

Statistics

6
Total Refusals
2
Unique Violations
9/17/2013
Latest Refusal
9/17/2013
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
31.3×30%
Recency
0.0×20%
Frequency
60.0×10%
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

1186×

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).

756×

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
9/17/2013
66VAL99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
Philadelphia District Office (PHI-DO)
9/17/2013
66VAL99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
Philadelphia District Office (PHI-DO)
9/17/2013
66VAL99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
Philadelphia District Office (PHI-DO)
9/17/2013
66VAL99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
Philadelphia District Office (PHI-DO)
9/17/2013
66VAL99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
Philadelphia District Office (PHI-DO)
9/17/2013
66VAL99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
Philadelphia District Office (PHI-DO)

Frequently Asked Questions

What is Acmt International ( Hk 0 Ltd.'s FDA import refusal history?

Acmt International ( Hk 0 Ltd. (FEI: 3010280663) has 6 FDA import refusal record(s) in our database, spanning from 9/17/2013 to 9/17/2013.

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. Acmt International ( Hk 0 Ltd.'s FEI number is 3010280663.

What types of violations has Acmt International ( Hk 0 Ltd. received?

Acmt International ( Hk 0 Ltd. 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 Acmt International ( Hk 0 Ltd. come from?

All FDA import refusal data for Acmt International ( Hk 0 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.