Syntex Healthcare Products Co., Ltd.
⚠️ High Risk
FEI: 3003736705 • Industrial Zone, Hebei Province • CHINA
FEI Number
3003736705
Location
Industrial Zone, Hebei Province
Country
CHINAAddress
No. 1 Fangjiazhuang, Xinji City, Industrial Zone, Hebei Province, 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.
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.
DEVGMPS
The article appears to be a device for which the methods, facilities, or controls used in, or the facilities or controls used for, its manufacture, packing, storage or installation do not conform to the requirements of Sec. 520(f) and any applicable variance under Sec. 520(f)(2).
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).
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.
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).
3905
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 |
|---|---|---|---|
| 12/11/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of West Coast Imports (DWCI) | |
| 10/22/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of West Coast Imports (DWCI) | |
| 10/22/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 10/22/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 10/22/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 10/22/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 7/25/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of West Coast Imports (DWCI) | |
| 6/21/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 6/21/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 6/21/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 6/21/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 6/21/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of West Coast Imports (DWCI) | |
| 6/17/2024 | 80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 5/23/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of Southwest Imports (DSWI) | |
| 5/23/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of Southwest Imports (DSWI) | |
| 5/23/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of Southwest Imports (DSWI) | |
| 5/23/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of Southwest Imports (DSWI) |
| 5/23/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of Southwest Imports (DSWI) |
| 5/14/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of West Coast Imports (DWCI) |
| 5/14/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of West Coast Imports (DWCI) |
| 5/7/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of West Coast Imports (DWCI) | |
| 5/4/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of West Coast Imports (DWCI) |
| 5/1/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 16DIRECTIONS | Division of West Coast Imports (DWCI) |
| 5/1/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 16DIRECTIONS | Division of West Coast Imports (DWCI) |
| 4/24/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of West Coast Imports (DWCI) |
| 4/2/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of West Coast Imports (DWCI) |
| 4/2/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of West Coast Imports (DWCI) |
| 4/2/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of West Coast Imports (DWCI) |
| 3/21/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of Southeast Imports (DSEI) |
| 3/21/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of Southeast Imports (DSEI) |
| 3/21/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of Southeast Imports (DSEI) |
| 5/16/2003 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 341REGISTERED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Syntex Healthcare Products Co., Ltd.'s FDA import refusal history?
Syntex Healthcare Products Co., Ltd. (FEI: 3003736705) has 32 FDA import refusal record(s) in our database, spanning from 5/16/2003 to 12/11/2024.
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. Syntex Healthcare Products Co., Ltd.'s FEI number is 3003736705.
What types of violations has Syntex Healthcare Products Co., Ltd. received?
Syntex Healthcare Products Co., Ltd. has been cited for 8 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 Syntex Healthcare Products Co., Ltd. come from?
All FDA import refusal data for Syntex Healthcare 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.