Shijiazhuang Wally Plastic Co., Ltd.
⚠️ Moderate Risk
FEI: 3003896660 • Jinzhou, Hebei • CHINA
FEI Number
3003896660
Location
Jinzhou, Hebei
Country
CHINAAddress
No. 78 Tongda Road, South of Weiwu Road, West of Jingsan Street, Jinzhou Economic Development Zone, Jinzhou, 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).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/30/2021 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of West Coast Imports (DWCI) |
| 8/30/2021 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of West Coast Imports (DWCI) |
| 8/10/2021 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of West Coast Imports (DWCI) |
| 8/10/2021 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of West Coast Imports (DWCI) |
| 8/10/2021 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of West Coast Imports (DWCI) |
| 7/26/2021 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of West Coast Imports (DWCI) |
| 2/27/2019 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of Southeast Imports (DSEI) |
| 8/10/2018 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/15/2018 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/13/2014 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | New England District Office (NWE-DO) |
| 11/30/2010 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | New York District Office (NYK-DO) |
| 11/1/2010 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | New York District Office (NYK-DO) |
| 5/5/2005 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Philadelphia District Office (PHI-DO) |
| 12/29/2003 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | Los Angeles District Office (LOS-DO) | |
| 12/29/2003 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | Los Angeles District Office (LOS-DO) | |
| 12/29/2003 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | Los Angeles District Office (LOS-DO) | |
| 12/29/2003 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Shijiazhuang Wally Plastic Co., Ltd.'s FDA import refusal history?
Shijiazhuang Wally Plastic Co., Ltd. (FEI: 3003896660) has 17 FDA import refusal record(s) in our database, spanning from 12/29/2003 to 8/30/2021.
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 Wally Plastic Co., Ltd.'s FEI number is 3003896660.
What types of violations has Shijiazhuang Wally Plastic Co., Ltd. received?
Shijiazhuang Wally Plastic Co., Ltd. has been cited for 4 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 Wally Plastic Co., Ltd. come from?
All FDA import refusal data for Shijiazhuang Wally 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.