NACROUS PLASTIC CO LTD
⚠️ High Risk
FEI: 3011587102 • SHIJIAZHUANG, HEBEI • CHINA
FEI Number
3011587102
Location
SHIJIAZHUANG, HEBEI
Country
CHINAAddress
XIBAIPO INDUSTRIAL ZOON, PINGSHAN COUNTY, SHIJIAZHUANG, HEBEI, China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/19/2017 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of Northeast Imports (DNEI) |
| 10/19/2017 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of Northeast Imports (DNEI) |
| 10/19/2017 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of Northeast Imports (DNEI) |
| 10/19/2017 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of Northeast Imports (DNEI) |
| 10/19/2017 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of Northeast Imports (DNEI) |
| 10/16/2017 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | Division of Southeast Imports (DSEI) | |
| 10/16/2017 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | Division of Southeast Imports (DSEI) | |
| 10/16/2017 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | Division of Southeast Imports (DSEI) | |
| 10/16/2017 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | Division of Southeast Imports (DSEI) | |
| 10/16/2017 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | Division of Southeast Imports (DSEI) | |
| 12/16/2016 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of West Coast Imports (DWCI) |
| 12/16/2016 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of West Coast Imports (DWCI) |
| 12/16/2016 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is NACROUS PLASTIC CO LTD's FDA import refusal history?
NACROUS PLASTIC CO LTD (FEI: 3011587102) has 13 FDA import refusal record(s) in our database, spanning from 12/16/2016 to 10/19/2017.
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. NACROUS PLASTIC CO LTD's FEI number is 3011587102.
What types of violations has NACROUS PLASTIC CO LTD received?
NACROUS PLASTIC CO LTD 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 NACROUS PLASTIC CO LTD come from?
All FDA import refusal data for NACROUS PLASTIC 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.