PCL INC
⚠️ Moderate Risk
FEI: 3012942266 • Geumcheon, Seoul Teugbyeolsi • SOUTH KOREA
FEI Number
3012942266
Location
Geumcheon, Seoul Teugbyeolsi
Country
SOUTH KOREAAddress
Rm 701 Star Valley 99 Digital-Ro 9-Gil, , Geumcheon, Seoul Teugbyeolsi, 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
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/14/2022 | 83OTGNON-SARS CORONAVIRUS MULTIPLEX NUCLEIC ACID ASSAY | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 9/23/2022 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/8/2022 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 11/30/2021 | 83QMNCOVID-19 MULTI-ANALYTE ANTIGEN DEVICE | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 7/15/2021 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 3/11/2021 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 9/8/2020 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 7/28/2020 | 83QHONUCLEIC-ACID TESTS USED FOR INFECTIOUS DISEASE SCREENING OF BLOOD AND PLASMA DONATIONS | 508NO 510(K) | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is PCL INC's FDA import refusal history?
PCL INC (FEI: 3012942266) has 8 FDA import refusal record(s) in our database, spanning from 7/28/2020 to 12/14/2022.
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. PCL INC's FEI number is 3012942266.
What types of violations has PCL INC received?
PCL INC 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 PCL INC come from?
All FDA import refusal data for PCL 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.