B. Braun Medical Ltd.
⚠️ Moderate Risk
FEI: 3002806422 • Sheffield South Yorkshire • UNITED KINGDOM
FEI Number
3002806422
Location
Sheffield South Yorkshire
Country
UNITED KINGDOMAddress
43 Allen Street, , Sheffield South Yorkshire, , 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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/28/2011 | 79HTDFORCEPS | New York District Office (NYK-DO) | |
| 1/14/2005 | 79KDGCHISEL (OSTEOTOME) | 2780DEVICEGMPS | Philadelphia District Office (PHI-DO) |
| 1/9/2003 | 84GWIDISCRIMINATOR,TWO-POINT | 2780DEVICEGMPS | Cincinnati District Office (CIN-DO) |
| 1/9/2003 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 2780DEVICEGMPS | Cincinnati District Office (CIN-DO) |
| 1/9/2003 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 2780DEVICEGMPS | Cincinnati District Office (CIN-DO) |
| 1/9/2003 | 76EMMCHISEL, OSTEOTOME, SURGICAL | 2780DEVICEGMPS | Cincinnati District Office (CIN-DO) |
| 1/9/2003 | 79EMFKNIFE, SURGICAL | 2780DEVICEGMPS | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is B. Braun Medical Ltd.'s FDA import refusal history?
B. Braun Medical Ltd. (FEI: 3002806422) has 7 FDA import refusal record(s) in our database, spanning from 1/9/2003 to 2/28/2011.
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. B. Braun Medical Ltd.'s FEI number is 3002806422.
What types of violations has B. Braun Medical Ltd. received?
B. Braun Medical 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 B. Braun Medical Ltd. come from?
All FDA import refusal data for B. Braun Medical 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.