A & H Design Group

⚠️ High Risk

FEI: 3009496071 • Hung Hom, Kowloon • HONG KONG

FEI

FEI Number

3009496071

📍

Location

Hung Hom, Kowloon

🇭🇰

Country

HONG KONG

🏢

Address

Suite 608, Hung Hom, Harbour Centre Tower 1; 1 Hok Cheung Street, Hung Hom, Kowloon, Hong Kong

High Risk

FDA Import Risk Assessment

55.2

LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

Total Refusals

Unique Violations

3/16/2017

Latest Refusal

9/8/2015

Earliest Refusal

Score Breakdown

Violation Severity

60.2×40%

Refusal Volume

70.5×30%

Recency

0.0×20%

Frequency

100.0×10%

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

Violation Summary

1668×

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.

11855×

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).

328052×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

50847×

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.

3411×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

Date	Product	Violations	Division
3/16/2017	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS	New Orleans District Office (NOL-DO)
9/2/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS	Division of Southeast Imports (DSEI)
9/2/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS	Division of Southeast Imports (DSEI)
8/2/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
8/2/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
7/26/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
7/26/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS 3280FRNMFGREG	Division of Southeast Imports (DSEI)
7/11/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
6/9/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS	New Orleans District Office (NOL-DO)
6/9/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS	New Orleans District Office (NOL-DO)
6/7/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS	New Orleans District Office (NOL-DO)
6/3/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
6/2/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS	New Orleans District Office (NOL-DO)
5/24/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
5/23/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
5/13/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS	Division of Southeast Imports (DSEI)
5/12/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
5/9/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
5/9/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
5/9/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG	New Orleans District Office (NOL-DO)
5/9/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG	New Orleans District Office (NOL-DO)
5/6/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
5/6/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
5/4/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
5/4/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
4/28/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
4/26/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG	New Orleans District Office (NOL-DO)
4/26/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS	Division of Southeast Imports (DSEI)
4/18/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
4/13/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
4/13/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
4/11/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
4/1/2016	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
3/24/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
3/16/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
3/14/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
3/14/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
3/14/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
3/14/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
3/14/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
3/14/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
3/14/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 16DIRECTIONS 508NO 510(K)	Division of Southeast Imports (DSEI)
3/11/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
3/9/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
2/23/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG 341REGISTERED	New Orleans District Office (NOL-DO)
2/23/2016	78PIAVIBRATOR FOR CLIMAX CONTROL OF PREMATURE EJACULATION	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG	Division of Southeast Imports (DSEI)
2/19/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED	Division of Southeast Imports (DSEI)
2/19/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED	Division of Southeast Imports (DSEI)
2/16/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED	Division of Southeast Imports (DSEI)
2/12/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
2/9/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED	Division of Southeast Imports (DSEI)
2/1/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
2/1/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
1/29/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
1/29/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
1/29/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
1/27/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
1/27/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
1/25/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
1/25/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
1/25/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
1/25/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
1/15/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
1/15/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
1/8/2016	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
12/1/2015	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS	New Orleans District Office (NOL-DO)
11/23/2015	89IROVIBRATOR, THERAPEUTIC	118NOT LISTED	Division of Southeast Imports (DSEI)
11/17/2015	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS	Division of Southeast Imports (DSEI)
11/17/2015	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS	Division of Southeast Imports (DSEI)
11/16/2015	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS	Division of Southeast Imports (DSEI)
11/6/2015	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS	Division of Southeast Imports (DSEI)
11/6/2015	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS	Division of Southeast Imports (DSEI)
11/6/2015	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS	Division of Southeast Imports (DSEI)
11/4/2015	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS	Division of Southeast Imports (DSEI)
10/30/2015	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS	Division of Southeast Imports (DSEI)
9/23/2015	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 3280FRNMFGREG	Division of Southeast Imports (DSEI)
9/22/2015	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS	Division of Southeast Imports (DSEI)
9/9/2015	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 508NO 510(K)	Division of Southeast Imports (DSEI)
9/8/2015	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS	Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is A & H Design Group's FDA import refusal history?

A & H Design Group (FEI: 3009496071) has 79 FDA import refusal record(s) in our database, spanning from 9/8/2015 to 3/16/2017.

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 Design Group's FEI number is 3009496071.

What types of violations has A & H Design Group received?

A & H Design Group has been cited for 5 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 Design Group come from?

All FDA import refusal data for A & H Design Group 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.