Tianjin Empecs Medical Device Co.,Ltd.
⚠️ Moderate Risk
FEI: 3003116995 • Tianjin • CHINA
FEI Number
3003116995
Location
Tianjin
Country
CHINAAddress
No. 35 and 37, Yingcheng Street, Hangu, Binhai New Area, Tianjin, , 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
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/28/2019 | 75JJXSINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED) | Division of Southeast Imports (DSEI) | |
| 1/9/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 3260NO ENGLISH | Los Angeles District Office (LOS-DO) |
| 1/9/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 3260NO ENGLISH | Los Angeles District Office (LOS-DO) |
| 1/9/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 3260NO ENGLISH | Los Angeles District Office (LOS-DO) |
| 1/9/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 3260NO ENGLISH | Los Angeles District Office (LOS-DO) |
| 1/9/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 3260NO ENGLISH | Los Angeles District Office (LOS-DO) |
| 1/9/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 3260NO ENGLISH | Los Angeles District Office (LOS-DO) |
| 1/9/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 3260NO ENGLISH | Los Angeles District Office (LOS-DO) |
| 1/9/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 3260NO ENGLISH | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Tianjin Empecs Medical Device Co.,Ltd.'s FDA import refusal history?
Tianjin Empecs Medical Device Co.,Ltd. (FEI: 3003116995) has 9 FDA import refusal record(s) in our database, spanning from 1/9/2014 to 3/28/2019.
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. Tianjin Empecs Medical Device Co.,Ltd.'s FEI number is 3003116995.
What types of violations has Tianjin Empecs Medical Device Co.,Ltd. received?
Tianjin Empecs Medical Device 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 Tianjin Empecs Medical Device Co.,Ltd. come from?
All FDA import refusal data for Tianjin Empecs Medical Device 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.