SUPER SAFE PLASTIC PRODUCTS CO., LTD.
⚠️ High Risk
FEI: 3006113146 • Shijiazhuang • CHINA
FEI Number
3006113146
Location
Shijiazhuang
Country
CHINAAddress
Meng Er Village East, Pingshan County, Shijiazhuang, , 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 |
|---|---|---|---|
| 11/12/2014 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Southwest Import District Office (SWI-DO) |
| 6/3/2014 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Chicago District Office (CHI-DO) |
| 6/3/2014 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Chicago District Office (CHI-DO) |
| 5/23/2014 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Southwest Import District Office (SWI-DO) |
| 5/21/2014 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 5/9/2014 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Chicago District Office (CHI-DO) |
| 4/28/2014 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Southwest Import District Office (SWI-DO) |
| 3/14/2014 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | San Francisco District Office (SAN-DO) |
| 3/14/2014 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | San Francisco District Office (SAN-DO) |
| 3/14/2014 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | San Francisco District Office (SAN-DO) |
| 1/14/2014 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Los Angeles District Office (LOS-DO) |
| 7/30/2012 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Southwest Import District Office (SWI-DO) |
| 7/30/2012 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Southwest Import District Office (SWI-DO) |
| 7/30/2012 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Southwest Import District Office (SWI-DO) |
| 7/30/2012 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Southwest Import District Office (SWI-DO) |
| 7/30/2012 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Southwest Import District Office (SWI-DO) |
| 7/30/2012 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Southwest Import District Office (SWI-DO) |
| 7/30/2012 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Southwest Import District Office (SWI-DO) |
| 7/30/2012 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Southwest Import District Office (SWI-DO) |
| 7/30/2012 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Southwest Import District Office (SWI-DO) |
| 7/30/2012 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Southwest Import District Office (SWI-DO) |
| 7/30/2012 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Southwest Import District Office (SWI-DO) |
| 7/30/2012 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Southwest Import District Office (SWI-DO) |
| 7/30/2012 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Southwest Import District Office (SWI-DO) |
| 7/30/2012 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Southwest Import District Office (SWI-DO) |
| 7/30/2012 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Southwest Import District Office (SWI-DO) |
| 10/12/2011 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Southwest Import District Office (SWI-DO) |
| 9/2/2011 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Atlanta District Office (ATL-DO) |
| 6/29/2011 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is SUPER SAFE PLASTIC PRODUCTS CO., LTD.'s FDA import refusal history?
SUPER SAFE PLASTIC PRODUCTS CO., LTD. (FEI: 3006113146) has 29 FDA import refusal record(s) in our database, spanning from 6/29/2011 to 11/12/2014.
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. SUPER SAFE PLASTIC PRODUCTS CO., LTD.'s FEI number is 3006113146.
What types of violations has SUPER SAFE PLASTIC PRODUCTS CO., LTD. received?
SUPER SAFE PLASTIC PRODUCTS 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 SUPER SAFE PLASTIC PRODUCTS CO., LTD. come from?
All FDA import refusal data for SUPER SAFE PLASTIC PRODUCTS 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.