Long First (Xiamen) Plastics Co., Ltd.
⚠️ Moderate Risk
FEI: 3002751308 • Xiamen Fujian • CHINA
FEI Number
3002751308
Location
Xiamen Fujian
Country
CHINAAddress
No. 11-19 Shuangfu Road, Tongan South Urban Industrial Areas, Xiamen Fujian, , China
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
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/1/2009 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Atlanta District Office (ATL-DO) |
| 6/1/2009 | 80NPCGLOVE, PATIENT EXAMINATION, POWDER FREE, | 477HOLES | Atlanta District Office (ATL-DO) |
| 3/31/2009 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | Seattle District Office (SEA-DO) | |
| 2/6/2009 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | New Orleans District Office (NOL-DO) |
| 3/10/2004 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Chicago District Office (CHI-DO) |
| 2/20/2004 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Philadelphia District Office (PHI-DO) |
Frequently Asked Questions
What is Long First (Xiamen) Plastics Co., Ltd.'s FDA import refusal history?
Long First (Xiamen) Plastics Co., Ltd. (FEI: 3002751308) has 6 FDA import refusal record(s) in our database, spanning from 2/20/2004 to 6/1/2009.
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. Long First (Xiamen) Plastics Co., Ltd.'s FEI number is 3002751308.
What types of violations has Long First (Xiamen) Plastics Co., Ltd. received?
Long First (Xiamen) Plastics 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 Long First (Xiamen) Plastics Co., Ltd. come from?
All FDA import refusal data for Long First (Xiamen) Plastics 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.