Smiths Medical ASD, Inc.
⚠️ Moderate Risk
FEI: 3007938030 • Dublin, OH • UNITED STATES
FEI Number
3007938030
Location
Dublin, OH
Country
UNITED STATESAddress
5200 Upper Metro Pl Ste 200, , Dublin, OH, 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).
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.
INSANITARY
The article is subject to refusal of admission pursuant to section 801(a)(3) in that the article appears to have been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
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 |
|---|---|---|---|
| 10/15/2021 | 80PNDNON-CORING (HUBER) NEEDLE | Division of Southeast Imports (DSEI) | |
| 3/6/2014 | 73BSJMASK, GAS, ANESTHETIC | New England District Office (NWE-DO) | |
| 3/6/2014 | 73BSJMASK, GAS, ANESTHETIC | New England District Office (NWE-DO) |
Frequently Asked Questions
What is Smiths Medical ASD, Inc.'s FDA import refusal history?
Smiths Medical ASD, Inc. (FEI: 3007938030) has 3 FDA import refusal record(s) in our database, spanning from 3/6/2014 to 10/15/2021.
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. Smiths Medical ASD, Inc.'s FEI number is 3007938030.
What types of violations has Smiths Medical ASD, Inc. received?
Smiths Medical ASD, Inc. 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 Smiths Medical ASD, Inc. come from?
All FDA import refusal data for Smiths Medical ASD, Inc. 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.