Ardeypharm GmbH
⚠️ Moderate Risk
FEI: 3008273811 • Herdecke, North Rhine-Westphalia • GERMANY
FEI Number
3008273811
Location
Herdecke, North Rhine-Westphalia
Country
GERMANYAddress
Loerfeld Str. 20, , Herdecke, North Rhine-Westphalia, Germany
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
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
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).
DR QUALITC
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the drug appears to be represented as not being recognized in an official compendium and appears its strength differs from or its quality or purity falls below, that which it purports or is represented to possess.
UNSAFE ADD
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.
NO ENGLISH
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/25/2012 | 66VIF99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 8/3/2011 | 66VCC99MISCELLANEOUS PATENT MEDICINES, ETC. | Philadelphia District Office (PHI-DO) | |
| 6/22/2011 | 41GDY99MEDICAL FOODS, N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 3/1/2007 | 41YHY99DIETARY CONVENTIONAL FOODS, N.E.C. | 238UNSAFE ADD | New Orleans District Office (NOL-DO) |
| 12/4/2006 | 54AEB99VITAMIN, N.E.C. | 324NO ENGLISH | New Orleans District Office (NOL-DO) |
| 10/24/2005 | 62IIF04ASPARAGINASE (ANTI-NEOPLASTIC) | New Orleans District Office (NOL-DO) | |
| 10/29/2004 | 55PP86CLOVE OIL (PHARMACEUTIC NECESSITY - FLAVOR) | 483DRUG NAME | New Orleans District Office (NOL-DO) |
| 10/29/2004 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 10/28/2004 | 56GAJ50NYSTATIN (ANTIFUNGAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/23/2004 | 56GCL50NYSTATIN (ANTIFUNGAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Ardeypharm GmbH's FDA import refusal history?
Ardeypharm GmbH (FEI: 3008273811) has 10 FDA import refusal record(s) in our database, spanning from 8/23/2004 to 5/25/2012.
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. Ardeypharm GmbH's FEI number is 3008273811.
What types of violations has Ardeypharm GmbH received?
Ardeypharm GmbH 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 Ardeypharm GmbH come from?
All FDA import refusal data for Ardeypharm GmbH 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.