Chromsystems Instruments & Chemicals GmbH
⚠️ Moderate Risk
FEI: 3003951180 • Grafelfing, Bavaria • GERMANY
FEI Number
3003951180
Location
Grafelfing, Bavaria
Country
GERMANYAddress
Am Haag 12, , Grafelfing, Bavaria, 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).
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/15/2020 | 91KZRCHROMATOGRAPHY (LIQUID, GEL), CLINICAL USE | Division of Northern Border Imports (DNBI) | |
| 10/27/2011 | 75JJXSINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED) | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 10/27/2011 | 75JJXSINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED) | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 9/14/2007 | 75JJXSINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 9/14/2007 | 83JSBCULTURE MEDIA, VITAMIN ASSAY | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 1/4/2007 | 88LDTREAGENT, GENERAL PURPOSE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 1/4/2007 | 88LDTREAGENT, GENERAL PURPOSE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 1/4/2007 | 88LDTREAGENT, GENERAL PURPOSE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 1/4/2007 | 88LDTREAGENT, GENERAL PURPOSE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Chromsystems Instruments & Chemicals GmbH's FDA import refusal history?
Chromsystems Instruments & Chemicals GmbH (FEI: 3003951180) has 9 FDA import refusal record(s) in our database, spanning from 1/4/2007 to 9/15/2020.
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. Chromsystems Instruments & Chemicals GmbH's FEI number is 3003951180.
What types of violations has Chromsystems Instruments & Chemicals GmbH received?
Chromsystems Instruments & Chemicals GmbH 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 Chromsystems Instruments & Chemicals GmbH come from?
All FDA import refusal data for Chromsystems Instruments & Chemicals 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.