Pharma Waldhof GmbH & Co. KG
⚠️ Moderate Risk
FEI: 3004058177 • Dusseldorf, North Rhine-Westphalia • GERMANY
FEI Number
3004058177
Location
Dusseldorf, North Rhine-Westphalia
Country
GERMANYAddress
Hansaallee 159, , Dusseldorf, 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).
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
MFR INSAN
The article is subject to refusal of admission pursuant to section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.
LACKS FIRM
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(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/16/2015 | 54YYS99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | New Orleans District Office (NOL-DO) | |
| 12/5/2014 | 65CCR01ADENOSINE PHOSPHATE (NUTRIENT/TONIC) | 75UNAPPROVED | Atlanta District Office (ATL-DO) |
| 7/13/2012 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 10/3/2005 | 65CCS01ADENOSINE PHOSPHATE (NUTRIENT/TONIC) | 16DIRECTIONS | Southwest Import District Office (SWI-DO) |
| 6/28/2005 | 54ADS06NIACIN (NICOTINIC ACID) (VITAMIN) | 308MFR INSAN | New Orleans District Office (NOL-DO) |
| 11/18/2004 | 65CIP01ADENOSINE PHOSPHATE (NUTRIENT/TONIC) | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Pharma Waldhof GmbH & Co. KG's FDA import refusal history?
Pharma Waldhof GmbH & Co. KG (FEI: 3004058177) has 6 FDA import refusal record(s) in our database, spanning from 11/18/2004 to 1/16/2015.
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. Pharma Waldhof GmbH & Co. KG's FEI number is 3004058177.
What types of violations has Pharma Waldhof GmbH & Co. KG received?
Pharma Waldhof GmbH & Co. KG has been cited for 5 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 Pharma Waldhof GmbH & Co. KG come from?
All FDA import refusal data for Pharma Waldhof GmbH & Co. KG 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.