Waldemar Link GmbH & Co. KG (Corp. Hq.)
⚠️ Moderate Risk
FEI: 3002808472 • Hamburg, Hamburg • GERMANY
FEI Number
3002808472
Location
Hamburg, Hamburg
Country
GERMANYAddress
Barkhausenweg 10, , Hamburg, Hamburg, 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
DEVICE GMP
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/10/2008 | 87HSNPROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER | 237NO PMA | New York District Office (NYK-DO) |
| 10/31/2001 | 87HSXPROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER | 226DEVICE GMP | New York District Office (NYK-DO) |
| 10/31/2001 | 87HSXPROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER | 226DEVICE GMP | New York District Office (NYK-DO) |
| 10/31/2001 | 87JDDPROSTHESIS, UPPER FEMORAL | 226DEVICE GMP | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Waldemar Link GmbH & Co. KG (Corp. Hq.)'s FDA import refusal history?
Waldemar Link GmbH & Co. KG (Corp. Hq.) (FEI: 3002808472) has 4 FDA import refusal record(s) in our database, spanning from 10/31/2001 to 9/10/2008.
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. Waldemar Link GmbH & Co. KG (Corp. Hq.)'s FEI number is 3002808472.
What types of violations has Waldemar Link GmbH & Co. KG (Corp. Hq.) received?
Waldemar Link GmbH & Co. KG (Corp. Hq.) has been cited for 2 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 Waldemar Link GmbH & Co. KG (Corp. Hq.) come from?
All FDA import refusal data for Waldemar Link GmbH & Co. KG (Corp. Hq.) 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.