Alfa Scientific Designs Inc
⚠️ Moderate Risk
FEI: 3001452245 • Poway, CA • UNITED STATES
FEI Number
3001452245
Location
Poway, CA
Country
UNITED STATESAddress
13200 Gregg St, , Poway, CA, 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
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).
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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 |
|---|---|---|---|
| 5/17/2022 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 1/13/2022 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | Division of West Coast Imports (DWCI) | |
| 3/27/2021 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 237NO PMA | Division of West Coast Imports (DWCI) |
| 9/2/2020 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | 508NO 510(K) | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Alfa Scientific Designs Inc's FDA import refusal history?
Alfa Scientific Designs Inc (FEI: 3001452245) has 4 FDA import refusal record(s) in our database, spanning from 9/2/2020 to 5/17/2022.
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. Alfa Scientific Designs Inc's FEI number is 3001452245.
What types of violations has Alfa Scientific Designs Inc received?
Alfa Scientific Designs 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 Alfa Scientific Designs Inc come from?
All FDA import refusal data for Alfa Scientific Designs 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.