Have & Be Co., Ltd.
⚠️ Moderate Risk
FEI: 3007648436 • Gangnam, Seoul • SOUTH KOREA
FEI Number
3007648436
Location
Gangnam, Seoul
Country
SOUTH KOREAAddress
769 8 Yeoksamng, , Gangnam, Seoul, South Korea
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
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).
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).
DR PACKGNG
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be a drug and its container is so made, formed, or filled as to be misleading
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/3/2014 | 53LF03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 8/19/2014 | 53LF03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 3602DR PACKGNG | Los Angeles District Office (LOS-DO) |
| 8/19/2014 | 53LF03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 3602DR PACKGNG | Los Angeles District Office (LOS-DO) |
| 10/18/2010 | 53GH06MAKEUP BASES (MAKEUP PREPARATIONS, NOT FOR EYES) | Los Angeles District Office (LOS-DO) | |
| 10/18/2010 | 53GH06MAKEUP BASES (MAKEUP PREPARATIONS, NOT FOR EYES) | Los Angeles District Office (LOS-DO) | |
| 10/18/2010 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 10/18/2010 | 53GH06MAKEUP BASES (MAKEUP PREPARATIONS, NOT FOR EYES) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 10/18/2010 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 10/18/2010 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 10/18/2010 | 53GH06MAKEUP BASES (MAKEUP PREPARATIONS, NOT FOR EYES) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Have & Be Co., Ltd.'s FDA import refusal history?
Have & Be Co., Ltd. (FEI: 3007648436) has 10 FDA import refusal record(s) in our database, spanning from 10/18/2010 to 11/3/2014.
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. Have & Be Co., Ltd.'s FEI number is 3007648436.
What types of violations has Have & Be Co., Ltd. received?
Have & Be Co., Ltd. has been cited for 3 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 Have & Be Co., Ltd. come from?
All FDA import refusal data for Have & Be 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.