Plworks Co, Ltd.
⚠️ Moderate Risk
FEI: 3007913779 • Yongin-Shi, Gyeonggido • SOUTH KOREA
FEI Number
3007913779
Location
Yongin-Shi, Gyeonggido
Country
SOUTH KOREAAddress
#12-18 Hanil-Ro, Giheung, , Yongin-Shi, Gyeonggido, 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
DRG REF EI
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article of drug appears to be adulterated under Section 501(j) because it has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/8/2024 | 65FAL06WATER, PURIFIED (EYEWASH) | 3845DRG REF EI | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Plworks Co, Ltd.'s FDA import refusal history?
Plworks Co, Ltd. (FEI: 3007913779) has 1 FDA import refusal record(s) in our database, spanning from 2/8/2024 to 2/8/2024.
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. Plworks Co, Ltd.'s FEI number is 3007913779.
What types of violations has Plworks Co, Ltd. received?
Plworks Co, Ltd. 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 Plworks Co, Ltd. come from?
All FDA import refusal data for Plworks 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.