Serva Electrophoresis Gmbh
⚠️ Moderate Risk
FEI: 3002521374 • Heidelberg, Baden-Wurttemberg • GERMANY
FEI Number
3002521374
Location
Heidelberg, Baden-Wurttemberg
Country
GERMANYAddress
Carl-Benz-Str. 7, , Heidelberg, 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
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).
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).
INSANITARY
The article is subject to refusal of admission pursuant to section 801(a)(3) in that the article appears to have been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
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.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/17/2014 | 88LDTREAGENT, GENERAL PURPOSE | New Orleans District Office (NOL-DO) | |
| 10/10/2013 | 64EAL99ENZYME N.E.C. | New Orleans District Office (NOL-DO) | |
| 10/10/2013 | 64EAL99ENZYME N.E.C. | New Orleans District Office (NOL-DO) | |
| 10/10/2013 | 64EAL99ENZYME N.E.C. | New Orleans District Office (NOL-DO) | |
| 8/31/2004 | 74LISHEPARIN COATING CHEMICALS, | 508NO 510(K) | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Serva Electrophoresis Gmbh's FDA import refusal history?
Serva Electrophoresis Gmbh (FEI: 3002521374) has 5 FDA import refusal record(s) in our database, spanning from 8/31/2004 to 10/17/2014.
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. Serva Electrophoresis Gmbh's FEI number is 3002521374.
What types of violations has Serva Electrophoresis Gmbh received?
Serva Electrophoresis 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 Serva Electrophoresis Gmbh come from?
All FDA import refusal data for Serva Electrophoresis 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.