Sony Medical Systems
⚠️ Moderate Risk
FEI: 3007225387 • North Attleboro, MA • UNITED STATES
FEI Number
3007225387
Location
North Attleboro, MA
Country
UNITED STATESAddress
49 Plain St, , North Attleboro, MA, 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/18/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/11/2016 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Sony Medical Systems's FDA import refusal history?
Sony Medical Systems (FEI: 3007225387) has 48 FDA import refusal record(s) in our database, spanning from 2/11/2016 to 2/18/2016.
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. Sony Medical Systems's FEI number is 3007225387.
What types of violations has Sony Medical Systems received?
Sony Medical Systems has been cited for 1 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 Sony Medical Systems come from?
All FDA import refusal data for Sony Medical Systems 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.