SARSTEDT AG & CO. KG
⚠️ Moderate Risk
FEI: 3002808075 • Numbrecht, North Rhine-Westphalia • GERMANY
FEI Number
3002808075
Location
Numbrecht, North Rhine-Westphalia
Country
GERMANYAddress
Sarstedtstr. 1, , Numbrecht, North Rhine-Westphalia, 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).
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).
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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 |
|---|---|---|---|
| 8/22/2025 | 75OIEURINE COLLECTION KIT (EXCLUDES HIV TESTING) | Division of Southeast Imports (DSEI) | |
| 9/26/2022 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 237NO PMA | Division of Southeast Imports (DSEI) |
| 8/11/2017 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is SARSTEDT AG & CO. KG's FDA import refusal history?
SARSTEDT AG & CO. KG (FEI: 3002808075) has 3 FDA import refusal record(s) in our database, spanning from 8/11/2017 to 8/22/2025.
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. SARSTEDT AG & CO. KG's FEI number is 3002808075.
What types of violations has SARSTEDT AG & CO. KG received?
SARSTEDT AG & CO. KG has been cited for 4 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 SARSTEDT AG & CO. KG come from?
All FDA import refusal data for SARSTEDT AG & CO. KG 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.