Shijiazhuang Brilliant Ocean Plastic Co., Ltd.
⚠️ Moderate Risk
FEI: 3004532785 • Luquan City Hebei, Hebei • CHINA
FEI Number
3004532785
Location
Luquan City Hebei, Hebei
Country
CHINAAddress
Century Industry Garden, Shangzhuang Town, Luquan City Hebei, Hebei, 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.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/1/2014 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 3280FRNMFGREG | Southwest Import District Office (SWI-DO) |
| 11/5/2009 | 80FMCGLOVE, PATIENT EXAMINATION | 477HOLES | New York District Office (NYK-DO) |
| 10/8/2009 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Los Angeles District Office (LOS-DO) |
| 9/9/2009 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | New England District Office (NWE-DO) |
| 8/25/2009 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of Southeast Imports (DSEI) |
| 8/6/2009 | 80FMCGLOVE, PATIENT EXAMINATION | 477HOLES | New York District Office (NYK-DO) |
| 7/8/2009 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Southwest Import District Office (SWI-DO) |
| 6/18/2009 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | New England District Office (NWE-DO) |
| 4/22/2009 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Atlanta District Office (ATL-DO) |
| 4/22/2009 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Atlanta District Office (ATL-DO) |
| 12/1/2008 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | New Orleans District Office (NOL-DO) |
| 12/1/2008 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | New Orleans District Office (NOL-DO) |
| 12/1/2008 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | New Orleans District Office (NOL-DO) |
| 12/1/2008 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | New Orleans District Office (NOL-DO) |
| 9/22/2006 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Atlanta District Office (ATL-DO) |
| 9/22/2006 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Atlanta District Office (ATL-DO) |
| 9/22/2006 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Atlanta District Office (ATL-DO) |
| 9/18/2006 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | New York District Office (NYK-DO) |
| 9/12/2006 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | Baltimore District Office (BLT-DO) | |
| 9/12/2006 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | Baltimore District Office (BLT-DO) | |
| 9/11/2006 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Los Angeles District Office (LOS-DO) |
| 8/8/2006 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Southwest Import District Office (SWI-DO) |
| 8/8/2006 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Southwest Import District Office (SWI-DO) |
| 7/5/2006 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Cincinnati District Office (CIN-DO) |
| 7/5/2006 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Cincinnati District Office (CIN-DO) |
| 6/7/2006 | 80FMCGLOVE, PATIENT EXAMINATION | 477HOLES | Cincinnati District Office (CIN-DO) |
| 6/5/2006 | 80NPCGLOVE, PATIENT EXAMINATION, POWDER FREE, | 477HOLES | New York District Office (NYK-DO) |
| 5/4/2006 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Atlanta District Office (ATL-DO) |
| 10/15/2004 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Atlanta District Office (ATL-DO) |
Frequently Asked Questions
What is Shijiazhuang Brilliant Ocean Plastic Co., Ltd.'s FDA import refusal history?
Shijiazhuang Brilliant Ocean Plastic Co., Ltd. (FEI: 3004532785) has 29 FDA import refusal record(s) in our database, spanning from 10/15/2004 to 7/1/2014.
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. Shijiazhuang Brilliant Ocean Plastic Co., Ltd.'s FEI number is 3004532785.
What types of violations has Shijiazhuang Brilliant Ocean Plastic Co., Ltd. received?
Shijiazhuang Brilliant Ocean Plastic Co., Ltd. has been cited for 3 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 Shijiazhuang Brilliant Ocean Plastic Co., Ltd. come from?
All FDA import refusal data for Shijiazhuang Brilliant Ocean 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.