Stanmore Implants Worldwide Ltd.
⚠️ Moderate Risk
FEI: 3004105610 • Borehamwood, Hertfordshire • UNITED KINGDOM
FEI Number
3004105610
Location
Borehamwood, Hertfordshire
Country
UNITED KINGDOMAddress
210 Centennial Avenue, Centennial Park, Borehamwood, Hertfordshire, United Kingdom
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
DEVICEGMPS
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.
DEVGMPS
The article appears to be a device for which the methods, facilities, or controls used in, or the facilities or controls used for, its manufacture, packing, storage or installation do not conform to the requirements of Sec. 520(f) and any applicable variance under Sec. 520(f)(2).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/13/2018 | 87KROPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER | 2780DEVICEGMPS | Division of Southwest Imports (DSWI) |
| 5/4/2018 | 87KROPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER | 2780DEVICEGMPS | Division of Northeast Imports (DNEI) |
| 5/4/2018 | 87KROPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER | 2780DEVICEGMPS | Division of Northeast Imports (DNEI) |
| 5/4/2018 | 87KROPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER | 2780DEVICEGMPS | Division of Northeast Imports (DNEI) |
| 5/4/2018 | 87KROPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER | 2780DEVICEGMPS | Division of Northeast Imports (DNEI) |
| 5/4/2018 | 87KROPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER | 2780DEVICEGMPS | Division of Northeast Imports (DNEI) |
| 1/11/2016 | 87JDGPROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL | Southwest Import District Office (SWI-DO) | |
| 3/10/2015 | 87HSDPROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED | 3724DEVGMPS | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Stanmore Implants Worldwide Ltd.'s FDA import refusal history?
Stanmore Implants Worldwide Ltd. (FEI: 3004105610) has 8 FDA import refusal record(s) in our database, spanning from 3/10/2015 to 6/13/2018.
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. Stanmore Implants Worldwide Ltd.'s FEI number is 3004105610.
What types of violations has Stanmore Implants Worldwide Ltd. received?
Stanmore Implants Worldwide Ltd. 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 Stanmore Implants Worldwide Ltd. come from?
All FDA import refusal data for Stanmore Implants Worldwide Ltd. 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.