Pharmazeutische Fabrik Dr. Reckeweg & Co. GmbH
⚠️ High Risk
FEI: 3002024829 • Bensheim, Hesse • GERMANY
FEI Number
3002024829
Location
Bensheim, Hesse
Country
GERMANYAddress
Berliner Ring 32, , Bensheim, Hesse, Germany
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/11/2025 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/28/2025 | 66XBL99HOMEOPATHIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/10/2024 | 62GDY99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/12/2023 | 63ABL99BONE CALCIUM REGULATOR N.E.C. | Division of Southeast Imports (DSEI) | |
| 12/19/2022 | 60LCA99ANALGESIC, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/19/2022 | 62VCA37RITONAVIR (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/8/2022 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/25/2022 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 10/25/2022 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 10/25/2022 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 10/25/2022 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 9/1/2022 | 66VSK99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 7/27/2022 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 7/27/2022 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 7/27/2022 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 4/28/2021 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/5/2021 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/8/2016 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/21/2006 | 66VPY99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Pharmazeutische Fabrik Dr. Reckeweg & Co. GmbH's FDA import refusal history?
Pharmazeutische Fabrik Dr. Reckeweg & Co. GmbH (FEI: 3002024829) has 19 FDA import refusal record(s) in our database, spanning from 10/21/2006 to 8/11/2025.
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. Pharmazeutische Fabrik Dr. Reckeweg & Co. GmbH's FEI number is 3002024829.
What types of violations has Pharmazeutische Fabrik Dr. Reckeweg & Co. GmbH received?
Pharmazeutische Fabrik Dr. Reckeweg & Co. GmbH 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 Pharmazeutische Fabrik Dr. Reckeweg & Co. GmbH come from?
All FDA import refusal data for Pharmazeutische Fabrik Dr. Reckeweg & Co. 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.