Vivida SA cc
⚠️ Moderate Risk
FEI: 3006589383 • Cape Town, Western Cape • SOUTH AFRICA
FEI Number
3006589383
Location
Cape Town, Western Cape
Country
SOUTH AFRICAAddress
183 Bree Street, , Cape Town, Western Cape, South Africa
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
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
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 |
|---|---|---|---|
| 6/19/2012 | 79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL | 508NO 510(K) | New England District Office (NWE-DO) |
| 6/19/2012 | 79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL | 508NO 510(K) | New England District Office (NWE-DO) |
| 3/30/2012 | 80LDQDEVICE, GENERAL MEDICAL | 508NO 510(K) | New England District Office (NWE-DO) |
| 3/30/2012 | 80LDQDEVICE, GENERAL MEDICAL | 508NO 510(K) | New England District Office (NWE-DO) |
| 3/30/2012 | 80LDQDEVICE, GENERAL MEDICAL | 508NO 510(K) | New England District Office (NWE-DO) |
| 3/30/2012 | 80LDQDEVICE, GENERAL MEDICAL | 508NO 510(K) | New England District Office (NWE-DO) |
| 3/27/2012 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 3/27/2012 | 79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 3/27/2012 | 79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 3/27/2012 | 79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 3/27/2012 | 79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/26/2011 | 79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL | Los Angeles District Office (LOS-DO) | |
| 10/26/2011 | 79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Vivida SA cc's FDA import refusal history?
Vivida SA cc (FEI: 3006589383) has 13 FDA import refusal record(s) in our database, spanning from 10/26/2011 to 6/19/2012.
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. Vivida SA cc's FEI number is 3006589383.
What types of violations has Vivida SA cc received?
Vivida SA cc 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 Vivida SA cc come from?
All FDA import refusal data for Vivida SA cc 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.