Herbal Technologies Bv
⚠️ High Risk
FEI: 3007225366 • Amsterdam, Noord-holland • NETHERLANDS
FEI Number
3007225366
Location
Amsterdam, Noord-holland
Country
NETHERLANDSAddress
Ruyschstraat 68, , Amsterdam, Noord-holland, Netherlands
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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).
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).
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).
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.
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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.
HEALTH C
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/7/2013 | 66V99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 10/16/2012 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 8/22/2012 | 66V99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 5/11/2012 | 66VDJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 12/19/2011 | 85HISCONDOM | Cincinnati District Office (CIN-DO) | |
| 9/12/2011 | 54FBZ99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 4/18/2011 | 85HISCONDOM | 237NO PMA | Philadelphia District Office (PHI-DO) |
| 4/18/2011 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 4/18/2011 | 66VBB99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 2/1/2011 | 85HISCONDOM | 237NO PMA | Philadelphia District Office (PHI-DO) |
| 2/1/2011 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 2/1/2011 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 2/1/2011 | 66VBB99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 9/13/2010 | 66YBA99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 4/27/2010 | 79MWZEXPANDER, BREAST, EXTERNAL | Cincinnati District Office (CIN-DO) | |
| 4/9/2010 | 89NZFMASSAGER, COSMETIC, STATIC ELECTRICITY-EMITTING | Cincinnati District Office (CIN-DO) | |
| 3/18/2010 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/21/2009 | 54FBS99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 488HEALTH C | Cincinnati District Office (CIN-DO) |
| 9/21/2009 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 5/11/2009 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 5/11/2009 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 5/11/2009 | 66VBA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
Frequently Asked Questions
What is Herbal Technologies Bv's FDA import refusal history?
Herbal Technologies Bv (FEI: 3007225366) has 22 FDA import refusal record(s) in our database, spanning from 5/11/2009 to 1/7/2013.
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. Herbal Technologies Bv's FEI number is 3007225366.
What types of violations has Herbal Technologies Bv received?
Herbal Technologies Bv has been cited for 7 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 Herbal Technologies Bv come from?
All FDA import refusal data for Herbal Technologies Bv 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.