Philosys Co. Ltd
⚠️ Moderate Risk
FEI: 3010172486 • Gunsan, Jeonrabuk • SOUTH KOREA
FEI Number
3010172486
Location
Gunsan, Jeonrabuk
Country
SOUTH KOREAAddress
28-5 Gwangwol-Gil, Okgu-Eup, Gunsan, Jeonrabuk, South Korea
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
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
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 |
|---|---|---|---|
| 2/23/2022 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 3/30/2021 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 3/30/2021 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 3/16/2021 | 75CGAGLUCOSE OXIDASE, GLUCOSE | 2780DEVICEGMPS | Division of Northern Border Imports (DNBI) |
| 3/16/2021 | 75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | 2780DEVICEGMPS | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Philosys Co. Ltd's FDA import refusal history?
Philosys Co. Ltd (FEI: 3010172486) has 5 FDA import refusal record(s) in our database, spanning from 3/16/2021 to 2/23/2022.
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. Philosys Co. Ltd's FEI number is 3010172486.
What types of violations has Philosys Co. Ltd received?
Philosys Co. Ltd has been cited for 3 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 Philosys Co. Ltd come from?
All FDA import refusal data for Philosys Co. Ltd 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.