Merz Pharma Gmbh & Co. KGaA
⚠️ High Risk
FEI: 3006999111 • Reinheim, Hassia • GERMANY
FEI Number
3006999111
Location
Reinheim, Hassia
Country
GERMANYAddress
Ludwigstr. 22, , Reinheim, Hassia, 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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/10/2025 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 341REGISTERED | Division of Northeast Imports (DNEI) |
| 4/30/2014 | 61HCO99ANTI-BACTERIAL, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/12/2013 | 53LY02DEPILATORIES (SKIN CARE PREPARATIONS) | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 3/26/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 3/21/2012 | 53LY06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/7/2012 | 66VBO99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Baltimore District Office (BLT-DO) |
| 2/7/2012 | 66VBO99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Baltimore District Office (BLT-DO) |
| 2/7/2012 | 66VBO99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Baltimore District Office (BLT-DO) |
| 2/7/2012 | 66VBO99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Baltimore District Office (BLT-DO) |
| 2/7/2012 | 66VBO99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Baltimore District Office (BLT-DO) |
| 2/7/2012 | 66VBO99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Baltimore District Office (BLT-DO) |
| 2/7/2012 | 66VBO99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Baltimore District Office (BLT-DO) |
Frequently Asked Questions
What is Merz Pharma Gmbh & Co. KGaA's FDA import refusal history?
Merz Pharma Gmbh & Co. KGaA (FEI: 3006999111) has 12 FDA import refusal record(s) in our database, spanning from 2/7/2012 to 2/10/2025.
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. Merz Pharma Gmbh & Co. KGaA's FEI number is 3006999111.
What types of violations has Merz Pharma Gmbh & Co. KGaA received?
Merz Pharma Gmbh & Co. KGaA 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 Merz Pharma Gmbh & Co. KGaA come from?
All FDA import refusal data for Merz Pharma Gmbh & Co. KGaA 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.