Meda Pharma Gmbh & Co. KG
⚠️ Moderate Risk
FEI: 3003569806 • Bad Homburg, Hesse • GERMANY
FEI Number
3003569806
Location
Bad Homburg, Hesse
Country
GERMANYAddress
Benzstr. 1, , Bad Homburg, Hesse, 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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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 GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/8/2023 | 61SCY04PIMECROLIMUS | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/19/2018 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/10/2016 | 66CBY99STOOL SOFTENER N.E.C. | Cincinnati District Office (CIN-DO) | |
| 9/16/2015 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 10/12/2012 | 60CCK04EPINEPHRINE (ADRENERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/19/2011 | 65QDA12CHLORPHENOXAMINE HCL (RELAXANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/4/2006 | 61XDS99ANTI-HISTAMINIC N.E.C. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Meda Pharma Gmbh & Co. KG's FDA import refusal history?
Meda Pharma Gmbh & Co. KG (FEI: 3003569806) has 7 FDA import refusal record(s) in our database, spanning from 4/4/2006 to 12/8/2023.
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. Meda Pharma Gmbh & Co. KG's FEI number is 3003569806.
What types of violations has Meda Pharma Gmbh & Co. KG received?
Meda Pharma 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 Meda Pharma Gmbh & Co. KG come from?
All FDA import refusal data for Meda Pharma 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.