Jiangsu Terra Medical Technology Co. Ltd.
⚠️ Moderate Risk
FEI: 3010806067 • Nantong, Jiangsu • CHINA
FEI Number
3010806067
Location
Nantong, Jiangsu
Country
CHINAAddress
No 2 Huimin East Rd., Rugao, Nantong, Jiangsu, 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
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).
REFUSE EI
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/3/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 7/30/2020 | 61HAY99ANTI-BACTERIAL, N.E.C. | Division of Northeast Imports (DNEI) | |
| 7/28/2020 | 61HAY99ANTI-BACTERIAL, N.E.C. | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Jiangsu Terra Medical Technology Co. Ltd.'s FDA import refusal history?
Jiangsu Terra Medical Technology Co. Ltd. (FEI: 3010806067) has 3 FDA import refusal record(s) in our database, spanning from 7/28/2020 to 9/3/2020.
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. Jiangsu Terra Medical Technology Co. Ltd.'s FEI number is 3010806067.
What types of violations has Jiangsu Terra Medical Technology Co. Ltd. received?
Jiangsu Terra Medical Technology 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 Jiangsu Terra Medical Technology Co. Ltd. come from?
All FDA import refusal data for Jiangsu Terra Medical Technology 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.