DR RECKEWEG & CO
⚠️ High Risk
FEI: 3012926030 • Bensheim, Hesse • GERMANY
FEI Number
3012926030
Location
Bensheim, Hesse
Country
GERMANYAddress
Berliner Ring 22, , 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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/24/2025 | 66XAL99HOMEOPATHIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/20/2025 | 66XDY06HOMEOPATHIC RESPIRATORY | Division of Southeast Imports (DSEI) | |
| 3/20/2025 | 66XDY06HOMEOPATHIC RESPIRATORY | Division of Southeast Imports (DSEI) | |
| 3/20/2025 | 66XDY02HOMEOPATHIC ALLERGY | Division of Southeast Imports (DSEI) | |
| 3/20/2025 | 66XDY99HOMEOPATHIC N.E.C. | Division of Southeast Imports (DSEI) | |
| 3/20/2025 | 66XDY06HOMEOPATHIC RESPIRATORY | Division of Southeast Imports (DSEI) | |
| 1/29/2025 | 54YGY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/27/2024 | 66VCB99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/3/2024 | 62QCA99ANTI-RHEUMATIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/20/2023 | 55RP99PHARMACEUTIC NECESSITIES, N.E.C. | Division of Southeast Imports (DSEI) | |
| 5/5/2023 | 65CBY99NUTRIENT/TONIC N.E.C. | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 5/5/2023 | 65CBY99NUTRIENT/TONIC N.E.C. | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 7/20/2022 | 60SCA99ANTACID, N.E.C. | Division of Southeast Imports (DSEI) | |
| 7/20/2022 | 62UCA99ANTI-TUSSIVE/COLD N.E.C. | Division of Southeast Imports (DSEI) | |
| 7/20/2022 | 62UCA99ANTI-TUSSIVE/COLD N.E.C. | Division of Southeast Imports (DSEI) | |
| 7/20/2022 | 62UCA99ANTI-TUSSIVE/COLD N.E.C. | Division of Southeast Imports (DSEI) | |
| 9/13/2021 | 65PDL99REGULATOR N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/11/2018 | 62GCK99ANTI-INFLAMMATORY N.E.C. | Division of Southeast Imports (DSEI) | |
| 12/11/2018 | 62GCK99ANTI-INFLAMMATORY N.E.C. | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is DR RECKEWEG & CO's FDA import refusal history?
DR RECKEWEG & CO (FEI: 3012926030) has 19 FDA import refusal record(s) in our database, spanning from 12/11/2018 to 6/24/2025.
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. DR RECKEWEG & CO's FEI number is 3012926030.
What types of violations has DR RECKEWEG & CO received?
DR RECKEWEG & CO has been cited for 3 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 DR RECKEWEG & CO come from?
All FDA import refusal data for DR RECKEWEG & CO 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.