Burg Apotheke
⚠️ Moderate Risk
FEI: 3003797952 • Bad Mergentheim, Baden-Wurttemberg • GERMANY
FEI Number
3003797952
Location
Bad Mergentheim, Baden-Wurttemberg
Country
GERMANYAddress
Burgstr. 28, , Bad Mergentheim, Baden-Wurttemberg, 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).
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/10/2012 | 66VDK99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 10/17/2003 | 60LCA99ANALGESIC, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/27/2002 | 54AFK90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 10/27/2002 | 54AFA99VITAMIN, N.E.C. | 179AGR RX | New Orleans District Office (NOL-DO) |
| 10/27/2002 | 54AFK99VITAMIN, N.E.C. | 179AGR RX | New Orleans District Office (NOL-DO) |
| 10/27/2002 | 54AFK05VITAMIN B12 (CYANOCOBALAMIN) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 10/27/2002 | 79GAANEEDLE, ASPIRATION AND INJECTION, DISPOSABLE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 10/27/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/27/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/27/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/27/2002 | 62GCA99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/27/2002 | 62GCA99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/27/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/27/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/27/2002 | 54AFK99VITAMIN, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/27/2002 | 54AFK99VITAMIN, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/27/2002 | 54AFK99VITAMIN, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/27/2002 | 28SGE02PLAIN SALT (TABLE SALT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Burg Apotheke's FDA import refusal history?
Burg Apotheke (FEI: 3003797952) has 18 FDA import refusal record(s) in our database, spanning from 10/27/2002 to 7/10/2012.
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. Burg Apotheke's FEI number is 3003797952.
What types of violations has Burg Apotheke received?
Burg Apotheke 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 Burg Apotheke come from?
All FDA import refusal data for Burg Apotheke 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.