Bereb Enterprise C
⚠️ Moderate Risk
FEI: 3007217431 • Taichung City • TAIWAN
FEI Number
3007217431
Location
Taichung City
Country
TAIWANAddress
10 6f S3 Hui Chung, , Taichung City, , Taiwan
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).
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.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/5/2009 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | San Francisco District Office (SAN-DO) |
| 1/5/2009 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | San Francisco District Office (SAN-DO) |
| 1/5/2009 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 1/5/2009 | 63VBJ99DEPIGMENTOR N.E.C. | San Francisco District Office (SAN-DO) | |
| 1/5/2009 | 63VBJ99DEPIGMENTOR N.E.C. | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Bereb Enterprise C's FDA import refusal history?
Bereb Enterprise C (FEI: 3007217431) has 5 FDA import refusal record(s) in our database, spanning from 1/5/2009 to 1/5/2009.
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. Bereb Enterprise C's FEI number is 3007217431.
What types of violations has Bereb Enterprise C received?
Bereb Enterprise C has been cited for 4 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 Bereb Enterprise C come from?
All FDA import refusal data for Bereb Enterprise C 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.