ImportRefusal LogoImportRefusal

Hug Communication

⚠️ Moderate Risk

FEI: 3010716904 • Tokyo • JAPAN

FEI

FEI Number

3010716904

📍

Location

Tokyo

🇯🇵

Country

JAPAN
🏢

Address

1-5-3-2f-B Nogata, , Tokyo, , Japan

Moderate Risk

FDA Import Risk Assessment

45.1
LowModerateHighCritical

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

Statistics

54
Total Refusals
5
Unique Violations
12/26/2014
Latest Refusal
11/26/2014
Earliest Refusal

Score Breakdown

Violation Severity
39.3×40%
Refusal Volume
64.5×30%
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

© ImportRefusal.com Original Analysis

Violation Summary

47144×

CSTIC LBLG

The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.

32607×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)

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).

32803×

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.

4723×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

Refusal History

DateProductViolationsDivision
12/26/2014
80LDQDEVICE, GENERAL MEDICAL
3260NO ENGLISH
Cincinnati District Office (CIN-DO)
12/26/2014
66P99ULTRAVIOLET SCREEN N.E.C.
472NO ENGLISH
Cincinnati District Office (CIN-DO)
12/23/2014
53BH01BATH OILS, TABLETS AND SALTS (BATH PREPARATIONS)
471CSTIC LBLG
Cincinnati District Office (CIN-DO)
12/15/2014
80LDQDEVICE, GENERAL MEDICAL
3260NO ENGLISH
Cincinnati District Office (CIN-DO)
12/15/2014
53LY01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Cincinnati District Office (CIN-DO)
12/15/2014
53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
471CSTIC LBLG
Cincinnati District Office (CIN-DO)
12/15/2014
53BH01BATH OILS, TABLETS AND SALTS (BATH PREPARATIONS)
471CSTIC LBLG
Cincinnati District Office (CIN-DO)
12/15/2014
53LD08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Cincinnati District Office (CIN-DO)
12/15/2014
53LD08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Cincinnati District Office (CIN-DO)
12/15/2014
66VAU99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
3280FRNMFGREG
472NO ENGLISH
Cincinnati District Office (CIN-DO)
12/12/2014
53AH02LOTIONS, OILS, POWDERS AND CREAMS (BABY PRODUCTS)
471CSTIC LBLG
Cincinnati District Office (CIN-DO)
12/12/2014
53LF99OTHER SKIN CARE PREPARATIONS, N.E.C.
471CSTIC LBLG
Cincinnati District Office (CIN-DO)
12/12/2014
53LF99OTHER SKIN CARE PREPARATIONS, N.E.C.
471CSTIC LBLG
Cincinnati District Office (CIN-DO)
12/12/2014
53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
471CSTIC LBLG
Cincinnati District Office (CIN-DO)
12/10/2014
53LY01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Cincinnati District Office (CIN-DO)
12/10/2014
53EA07TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING)
471CSTIC LBLG
Cincinnati District Office (CIN-DO)
12/10/2014
53EA07TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING)
471CSTIC LBLG
Cincinnati District Office (CIN-DO)
12/10/2014
53LY01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Cincinnati District Office (CIN-DO)
12/10/2014
53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C.
471CSTIC LBLG
Cincinnati District Office (CIN-DO)
12/10/2014
53EA07TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING)
471CSTIC LBLG
Cincinnati District Office (CIN-DO)
12/10/2014
53LD08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Cincinnati District Office (CIN-DO)
12/10/2014
53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
471CSTIC LBLG
Cincinnati District Office (CIN-DO)
12/10/2014
53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
471CSTIC LBLG
Cincinnati District Office (CIN-DO)
12/10/2014
53LD08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Cincinnati District Office (CIN-DO)
12/9/2014
53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
471CSTIC LBLG
Cincinnati District Office (CIN-DO)
12/9/2014
53EG99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C.
471CSTIC LBLG
Cincinnati District Office (CIN-DO)
12/9/2014
53YF99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C.
471CSTIC LBLG
Cincinnati District Office (CIN-DO)
12/9/2014
53LY01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Cincinnati District Office (CIN-DO)
12/9/2014
53LY01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Cincinnati District Office (CIN-DO)
12/9/2014
80LDQDEVICE, GENERAL MEDICAL
118NOT LISTED
3260NO ENGLISH
3280FRNMFGREG
Cincinnati District Office (CIN-DO)
12/9/2014
80LDQDEVICE, GENERAL MEDICAL
118NOT LISTED
3260NO ENGLISH
3280FRNMFGREG
Cincinnati District Office (CIN-DO)
12/8/2014
80LDQDEVICE, GENERAL MEDICAL
3260NO ENGLISH
Cincinnati District Office (CIN-DO)
12/8/2014
80LDQDEVICE, GENERAL MEDICAL
3260NO ENGLISH
Cincinnati District Office (CIN-DO)
12/8/2014
62WBR99ASTRINGENT/ANTI-PERSPIRANT N.E.C.
472NO ENGLISH
Cincinnati District Office (CIN-DO)
12/8/2014
53LD08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Cincinnati District Office (CIN-DO)
12/8/2014
53CY02EYELINER (EYE MAKEUP PREPARATIONS)
471CSTIC LBLG
Cincinnati District Office (CIN-DO)
12/8/2014
53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C.
471CSTIC LBLG
Cincinnati District Office (CIN-DO)
12/8/2014
53LD08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Cincinnati District Office (CIN-DO)
12/8/2014
53CY02EYELINER (EYE MAKEUP PREPARATIONS)
471CSTIC LBLG
Cincinnati District Office (CIN-DO)
12/8/2014
53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
471CSTIC LBLG
Cincinnati District Office (CIN-DO)
12/8/2014
53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
471CSTIC LBLG
Cincinnati District Office (CIN-DO)
12/8/2014
53LD08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Cincinnati District Office (CIN-DO)
12/8/2014
53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
471CSTIC LBLG
Cincinnati District Office (CIN-DO)
12/8/2014
53BC99OTHER BATH PREPARATIONS, N.E.C.
471CSTIC LBLG
Cincinnati District Office (CIN-DO)
12/8/2014
53JD99OTHER PERSONAL CLEANLINESS PRODUCTS (NOT ANTIPERSPIRANT), N.E.C.
471CSTIC LBLG
Cincinnati District Office (CIN-DO)
12/8/2014
53LD08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Cincinnati District Office (CIN-DO)
12/8/2014
53LD08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Cincinnati District Office (CIN-DO)
12/5/2014
53LY01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Cincinnati District Office (CIN-DO)
12/5/2014
53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
471CSTIC LBLG
Cincinnati District Office (CIN-DO)
12/5/2014
53EA07TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING)
471CSTIC LBLG
Cincinnati District Office (CIN-DO)
12/5/2014
53EA07TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING)
471CSTIC LBLG
Cincinnati District Office (CIN-DO)
12/5/2014
53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
471CSTIC LBLG
Cincinnati District Office (CIN-DO)
11/26/2014
80LDQDEVICE, GENERAL MEDICAL
3260NO ENGLISH
Cincinnati District Office (CIN-DO)
11/26/2014
53LY01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Hug Communication's FDA import refusal history?

Hug Communication (FEI: 3010716904) has 54 FDA import refusal record(s) in our database, spanning from 11/26/2014 to 12/26/2014.

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. Hug Communication's FEI number is 3010716904.

What types of violations has Hug Communication received?

Hug Communication 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 Hug Communication come from?

All FDA import refusal data for Hug Communication 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.