Bard Shannon Limited
⚠️ Moderate Risk
FEI: 3005636544 • Rio Abajo HUMACAO, PR • UNITED STATES
FEI Number
3005636544
Location
Rio Abajo HUMACAO, PR
Country
UNITED STATESAddress
San Geronimo Industrial Park, Lot No. 1 Road No. 3 Km. 76.7, Rio Abajo HUMACAO, PR, United States
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/16/2014 | 78KGCTUBE, GASTRO-ENTEROSTOMY | Southwest Import District Office (SWI-DO) | |
| 12/16/2014 | 78KNXCOLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER | Southwest Import District Office (SWI-DO) | |
| 12/16/2014 | 79FTLMESH, SURGICAL, POLYMERIC | Southwest Import District Office (SWI-DO) | |
| 12/16/2014 | 79FTLMESH, SURGICAL, POLYMERIC | Southwest Import District Office (SWI-DO) | |
| 12/16/2014 | 78KGCTUBE, GASTRO-ENTEROSTOMY | Southwest Import District Office (SWI-DO) | |
| 12/16/2014 | 78KGCTUBE, GASTRO-ENTEROSTOMY | Southwest Import District Office (SWI-DO) | |
| 3/23/2012 | 79FTLMESH, SURGICAL, POLYMERIC | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 11/17/2011 | 79FTLMESH, SURGICAL, POLYMERIC | 118NOT LISTED | Atlanta District Office (ATL-DO) |
Frequently Asked Questions
What is Bard Shannon Limited's FDA import refusal history?
Bard Shannon Limited (FEI: 3005636544) has 8 FDA import refusal record(s) in our database, spanning from 11/17/2011 to 12/16/2014.
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. Bard Shannon Limited's FEI number is 3005636544.
What types of violations has Bard Shannon Limited received?
Bard Shannon Limited 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 Bard Shannon Limited come from?
All FDA import refusal data for Bard Shannon Limited 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.