Amsino Medical (Kunshan) Co., Ltd.

⚠️ High Risk

FEI: 3005669815 • Suzhou, Jiangsu • CHINA

FEI

FEI Number

3005669815

📍

Location

Suzhou, Jiangsu

🇨🇳

Country

CHINA

🏢

Address

582 Lidou Road, Qiandengzhen Kunshan, Suzhou, Jiangsu, China

High Risk

FDA Import Risk Assessment

58.4

LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

Total Refusals

Unique Violations

10/6/2023

Latest Refusal

4/8/2013

Earliest Refusal

Score Breakdown

Violation Severity

55.4×40%

Refusal Volume

65.9×30%

Recency

54.5×20%

Frequency

56.2×10%

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

Violation Summary

11850×

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).

50826×

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.

3415×

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).

32804×

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.

161×

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.

2371×

NO PMA

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).

Refusal History

Date	Product	Violations	Division
10/6/2023	80FMHCONTAINER, SPECIMEN	16DIRECTIONS	Division of West Coast Imports (DWCI)
11/22/2019	80BRZSET, BLOOD TRANSFUSION	118NOT LISTED	Division of Southeast Imports (DSEI)
3/29/2019	80BRZSET, BLOOD TRANSFUSION	118NOT LISTED	Division of Southeast Imports (DSEI)
1/29/2019	80BRZSET, BLOOD TRANSFUSION	118NOT LISTED	Division of Southeast Imports (DSEI)
11/20/2018	80BRZSET, BLOOD TRANSFUSION	341REGISTERED	Division of Southeast Imports (DSEI)
11/2/2018	80BRZSET, BLOOD TRANSFUSION	118NOT LISTED	Division of Southeast Imports (DSEI)
10/4/2018	80BRZSET, BLOOD TRANSFUSION	118NOT LISTED	Division of Southeast Imports (DSEI)
9/28/2018	80BRZSET, BLOOD TRANSFUSION	118NOT LISTED	Division of Southeast Imports (DSEI)
9/28/2018	80BRZSET, BLOOD TRANSFUSION	118NOT LISTED	Division of Southeast Imports (DSEI)
7/20/2018	80BRZSET, BLOOD TRANSFUSION	118NOT LISTED	Division of Southeast Imports (DSEI)
3/30/2018	80BRZSET, BLOOD TRANSFUSION	508NO 510(K)	Division of Southeast Imports (DSEI)
3/30/2018	80BRZSET, BLOOD TRANSFUSION	508NO 510(K)	Division of Southeast Imports (DSEI)
3/16/2018	80BRZSET, BLOOD TRANSFUSION	118NOT LISTED	Division of Southeast Imports (DSEI)
2/26/2018	80BRZSET, BLOOD TRANSFUSION	118NOT LISTED 3280FRNMFGREG	Division of Southeast Imports (DSEI)
2/12/2018	80BRZSET, BLOOD TRANSFUSION	118NOT LISTED	Division of Southeast Imports (DSEI)
1/4/2018	80BRZSET, BLOOD TRANSFUSION	118NOT LISTED	Division of Southeast Imports (DSEI)
9/22/2017	80BRZSET, BLOOD TRANSFUSION	118NOT LISTED	Division of Southeast Imports (DSEI)
5/31/2017	80BRZSET, BLOOD TRANSFUSION	118NOT LISTED 508NO 510(K)	Division of Southeast Imports (DSEI)
5/11/2017	80BRZSET, BLOOD TRANSFUSION	118NOT LISTED 508NO 510(K)	Division of Southeast Imports (DSEI)
5/8/2017	80BRZSET, BLOOD TRANSFUSION	237NO PMA	Division of Southeast Imports (DSEI)
4/7/2017	80BRZSET, BLOOD TRANSFUSION	118NOT LISTED 508NO 510(K)	Division of Southeast Imports (DSEI)
3/17/2017	80BRZSET, BLOOD TRANSFUSION	118NOT LISTED	Division of Southeast Imports (DSEI)
2/24/2017	80BRZSET, BLOOD TRANSFUSION	118NOT LISTED	Division of Southeast Imports (DSEI)
2/2/2017	80BRZSET, BLOOD TRANSFUSION	341REGISTERED	Division of Southeast Imports (DSEI)
10/17/2016	80BRZSET, BLOOD TRANSFUSION	118NOT LISTED 3280FRNMFGREG	Division of Southeast Imports (DSEI)
7/25/2016	80BRZSET, BLOOD TRANSFUSION	118NOT LISTED 508NO 510(K)	Division of Southeast Imports (DSEI)
6/24/2016	80BRZSET, BLOOD TRANSFUSION	118NOT LISTED 508NO 510(K)	Division of Southeast Imports (DSEI)
4/20/2016	80BRZSET, BLOOD TRANSFUSION	118NOT LISTED 508NO 510(K)	Division of Southeast Imports (DSEI)
4/20/2016	57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE	118NOT LISTED	Division of Southeast Imports (DSEI)
3/16/2016	80BRZSET, BLOOD TRANSFUSION	118NOT LISTED 508NO 510(K)	Division of Southeast Imports (DSEI)
12/31/2015	80BRZSET, BLOOD TRANSFUSION	118NOT LISTED	Division of Southeast Imports (DSEI)
10/29/2015	80BRZSET, BLOOD TRANSFUSION	118NOT LISTED	Division of Southeast Imports (DSEI)
10/15/2015	78FAQBAG, URINE COLLECTION, LEG, FOR EXTERNAL USE	118NOT LISTED 508NO 510(K)	Division of Southeast Imports (DSEI)
10/15/2015	80BRZSET, BLOOD TRANSFUSION	118NOT LISTED 508NO 510(K)	Division of Southeast Imports (DSEI)
9/28/2015	80LDQDEVICE, GENERAL MEDICAL	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
9/28/2015	80BRZSET, BLOOD TRANSFUSION	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
9/14/2015	80BRZSET, BLOOD TRANSFUSION	118NOT LISTED 508NO 510(K)	Division of Southeast Imports (DSEI)
9/14/2015	57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE	118NOT LISTED	Division of Southeast Imports (DSEI)
7/14/2015	80BRZSET, BLOOD TRANSFUSION	118NOT LISTED 508NO 510(K)	Division of Southeast Imports (DSEI)
7/14/2015	57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE	118NOT LISTED	Division of Southeast Imports (DSEI)
6/11/2015	78FAQBAG, URINE COLLECTION, LEG, FOR EXTERNAL USE	118NOT LISTED	Division of Southeast Imports (DSEI)
6/11/2015	57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE	118NOT LISTED	Division of Southeast Imports (DSEI)
5/22/2015	80BRZSET, BLOOD TRANSFUSION	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
4/27/2015	57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE	118NOT LISTED	Division of Southeast Imports (DSEI)
4/3/2015	80BRZSET, BLOOD TRANSFUSION	118NOT LISTED 508NO 510(K)	Division of Southeast Imports (DSEI)
3/20/2015	80BRZSET, BLOOD TRANSFUSION	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
3/20/2015	57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE	118NOT LISTED	Division of Southeast Imports (DSEI)
3/3/2015	57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE	118NOT LISTED	Division of Southeast Imports (DSEI)
3/3/2015	57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE	118NOT LISTED	Division of Southeast Imports (DSEI)
11/14/2014	80BRZSET, BLOOD TRANSFUSION	118NOT LISTED 508NO 510(K)	Division of Southeast Imports (DSEI)
8/22/2014	80BRZSET, BLOOD TRANSFUSION	118NOT LISTED 508NO 510(K)	Division of Southeast Imports (DSEI)
1/28/2014	80LDQDEVICE, GENERAL MEDICAL	118NOT LISTED	Division of Southeast Imports (DSEI)
12/26/2013	78NNWBAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, NON-STERILE	118NOT LISTED 508NO 510(K)	Division of Southeast Imports (DSEI)
12/26/2013	80BRZSET, BLOOD TRANSFUSION	118NOT LISTED 508NO 510(K)	Division of Southeast Imports (DSEI)
7/2/2013	80BRZSET, BLOOD TRANSFUSION	118NOT LISTED 508NO 510(K)	Division of Southeast Imports (DSEI)
6/13/2013	80BRZSET, BLOOD TRANSFUSION	118NOT LISTED 508NO 510(K)	Division of Southeast Imports (DSEI)
5/3/2013	80BRZSET, BLOOD TRANSFUSION	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
4/10/2013	80BRZSET, BLOOD TRANSFUSION	118NOT LISTED 3280FRNMFGREG	Division of Southeast Imports (DSEI)
4/8/2013	80BRZSET, BLOOD TRANSFUSION	118NOT LISTED 508NO 510(K)	Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Amsino Medical (Kunshan) Co., Ltd.'s FDA import refusal history?

Amsino Medical (Kunshan) Co., Ltd. (FEI: 3005669815) has 59 FDA import refusal record(s) in our database, spanning from 4/8/2013 to 10/6/2023.

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. Amsino Medical (Kunshan) Co., Ltd.'s FEI number is 3005669815.

What types of violations has Amsino Medical (Kunshan) Co., Ltd. received?

Amsino Medical (Kunshan) Co., Ltd. has been cited for 6 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 Amsino Medical (Kunshan) Co., Ltd. come from?

All FDA import refusal data for Amsino Medical (Kunshan) 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.