COPIOUS INTL., INC.
⚠️ Moderate Risk
FEI: 3003753496 • Heyuan, Guangdong • CHINA
FEI Number
3003753496
Location
Heyuan, Guangdong
Country
CHINAAddress
Wei 11th Road, Huada St., New City Area, Heyuan, Guangdong, 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.
SOAKED/WET
The article appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health in that it appears to been held in water.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/15/2013 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 152SOAKED/WET | New Orleans District Office (NOL-DO) |
| 3/10/2009 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | New Orleans District Office (NOL-DO) |
| 3/10/2009 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | New Orleans District Office (NOL-DO) |
| 3/10/2009 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | New Orleans District Office (NOL-DO) |
| 3/10/2009 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | New Orleans District Office (NOL-DO) |
| 3/10/2009 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | New Orleans District Office (NOL-DO) |
| 3/10/2009 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Southwest Import District Office (SWI-DO) |
| 10/9/2008 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Baltimore District Office (BLT-DO) |
Frequently Asked Questions
What is COPIOUS INTL., INC.'s FDA import refusal history?
COPIOUS INTL., INC. (FEI: 3003753496) has 8 FDA import refusal record(s) in our database, spanning from 10/9/2008 to 4/15/2013.
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. COPIOUS INTL., INC.'s FEI number is 3003753496.
What types of violations has COPIOUS INTL., INC. received?
COPIOUS INTL., INC. has been cited for 5 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 COPIOUS INTL., INC. come from?
All FDA import refusal data for COPIOUS INTL., 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.