Siegfried Hameln GmbH
⚠️ Moderate Risk
FEI: 3002807877 • Hameln, Lower Saxony • GERMANY
FEI Number
3002807877
Location
Hameln, Lower Saxony
Country
GERMANYAddress
Langes Feld 13, , Hameln, Lower Saxony, 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).
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).
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.
INVDEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a device for investigational use for which no exemption has been granted as prescribed by Section 520(g)
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/15/2018 | 61TCP12METOCLOPRAMIDE HCL (ANTI-EMETIC/NAUSEANT) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/5/2018 | 66YDK99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 4/5/2018 | 66YDK99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 4/5/2018 | 66YDK99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 3/9/2018 | 61TCP12METOCLOPRAMIDE HCL (ANTI-EMETIC/NAUSEANT) | Division of Southeast Imports (DSEI) | |
| 3/9/2018 | 60TCP14NALOXONE HCL (ANTAGONIST) | Division of Southeast Imports (DSEI) | |
| 4/25/2016 | 65QCP63ROCURONIUM BROMIDE (RELAXANT) | Baltimore District Office (BLT-DO) | |
| 1/8/2013 | 65FBK04WATER (PHARM AID) FOR INJ, STERILE, U.S.P. | Division of Northeast Imports (DNEI) | |
| 10/12/2012 | 65RDK01CALCIUM CHLORIDE (REPLENISHER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/8/2012 | 78OGMCATHETER LOCK SOLUTION, HEMODIALYSIS | 3081INVDEVICE | Philadelphia District Office (PHI-DO) |
| 2/8/2012 | 66VIR99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 11/18/2004 | 66VCK99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Siegfried Hameln GmbH's FDA import refusal history?
Siegfried Hameln GmbH (FEI: 3002807877) has 12 FDA import refusal record(s) in our database, spanning from 11/18/2004 to 5/15/2018.
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. Siegfried Hameln GmbH's FEI number is 3002807877.
What types of violations has Siegfried Hameln GmbH received?
Siegfried Hameln 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 Siegfried Hameln GmbH come from?
All FDA import refusal data for Siegfried Hameln 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.