Hug Communication
⚠️ Moderate Risk
FEI: 3010987375 • Nakano-ku, Tokyo-to • JAPAN
FEI Number
3010987375
Location
Nakano-ku, Tokyo-to
Country
JAPANAddress
1-5-3 Nogata Nakano-Kunakano-Ku, , Nakano-ku, Tokyo-to, Japan
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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.
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).
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
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 |
|---|---|---|---|
| 12/8/2014 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 471CSTIC LBLG | Cincinnati District Office (CIN-DO) |
| 12/8/2014 | 53CY99OTHER EYE MAKEUP PREPARATIONS, N.E.C. | 471CSTIC LBLG | Cincinnati District Office (CIN-DO) |
| 12/8/2014 | 66PAY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 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) |
| 11/26/2014 | 53EY03HAIR STRAIGHTENERS (HAIR PREPARATIONS, NON-COLORING) | 471CSTIC LBLG | Cincinnati District Office (CIN-DO) |
| 11/26/2014 | 53GY09FACE MAKEUP KITS (MAKEUP PREPARATIONS, NOT FOR EYES) | 471CSTIC LBLG | Cincinnati District Office (CIN-DO) |
| 11/25/2014 | 53LY01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Cincinnati District Office (CIN-DO) |
| 11/25/2014 | 53LY01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Cincinnati District Office (CIN-DO) |
| 11/18/2014 | 80LDQDEVICE, GENERAL MEDICAL | Cincinnati District Office (CIN-DO) | |
| 11/18/2014 | 53LY01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Cincinnati District Office (CIN-DO) |
| 11/12/2014 | 79LRQTRACHEOSTOMY AND NASAL SUCTIONING KIT | Cincinnati District Office (CIN-DO) | |
| 9/25/2014 | 65LBJ11TITANIUM DIOXIDE (PROTECTANT) | Cincinnati District Office (CIN-DO) | |
| 9/25/2014 | 65LBJ11TITANIUM DIOXIDE (PROTECTANT) | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Hug Communication's FDA import refusal history?
Hug Communication (FEI: 3010987375) has 13 FDA import refusal record(s) in our database, spanning from 9/25/2014 to 12/8/2014.
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 3010987375.
What types of violations has Hug Communication received?
Hug Communication has been cited for 6 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.