Letcom Medical Products Co.,Ltd.
⚠️ High Risk
FEI: 3014626344 • Tianjin, Tianjin • CHINA
FEI Number
3014626344
Location
Tianjin, Tianjin
Country
CHINAAddress
No. 66 Zhen Dong Road, Dongli, Tianjin, Tianjin, 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.
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/31/2023 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 126FAILS STD | Division of Southwest Imports (DSWI) |
| 10/31/2023 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 126FAILS STD | Division of Southwest Imports (DSWI) |
| 10/31/2023 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 126FAILS STD | Division of Southwest Imports (DSWI) |
| 10/13/2023 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Division of Southwest Imports (DSWI) |
| 10/13/2023 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Division of Southwest Imports (DSWI) |
| 10/13/2023 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Division of Southwest Imports (DSWI) |
| 9/19/2023 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 8/30/2023 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of Northeast Imports (DNEI) |
| 8/30/2023 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of Northeast Imports (DNEI) |
| 8/30/2023 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Letcom Medical Products Co.,Ltd.'s FDA import refusal history?
Letcom Medical Products Co.,Ltd. (FEI: 3014626344) has 10 FDA import refusal record(s) in our database, spanning from 8/30/2023 to 10/31/2023.
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. Letcom Medical Products Co.,Ltd.'s FEI number is 3014626344.
What types of violations has Letcom Medical Products Co.,Ltd. received?
Letcom Medical Products 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 Letcom Medical Products Co.,Ltd. come from?
All FDA import refusal data for Letcom Medical 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.