Flextronics Medical Device Manufacturing(Shenzhen) Co., Ltd.

⚠️ Moderate Risk

FEI: 3004173703 • Shenzhen, Guangdong • CHINA

FEI

FEI Number

3004173703

📍

Location

Shenzhen, Guangdong

🇨🇳

Country

CHINA

🏢

Address

Longzhu, Xixiang, 3-6/F Building 1, 3b/F, 4/F, Building 2, And 5-7/F, Building 3, Rundongsheng Industrial; Baoan, Shenzhen, Guangdong, China

Moderate Risk

FDA Import Risk Assessment

41.4

LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

Total Refusals

Unique Violations

5/3/2022

Latest Refusal

6/2/2006

Earliest Refusal

Score Breakdown

Violation Severity

51.4×40%

Refusal Volume

48.2×30%

Recency

25.7×20%

Frequency

11.9×10%

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

11813×

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).

50813×

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.

34111×

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).

32805×

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.

Refusal History

Date	Product	Violations	Division
5/3/2022	75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
11/1/2013	75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	New Orleans District Office (NOL-DO)
11/1/2013	75LFRGLUCOSE DEHYDROGENASE, GLUCOSE	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	New Orleans District Office (NOL-DO)
11/1/2013	75LFRGLUCOSE DEHYDROGENASE, GLUCOSE	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	New Orleans District Office (NOL-DO)
11/1/2013	75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER	118NOT LISTED 508NO 510(K)	New Orleans District Office (NOL-DO)
11/1/2013	75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER	118NOT LISTED 508NO 510(K)	New Orleans District Office (NOL-DO)
11/1/2013	80LZGPUMP, INFUSION, INSULIN	118NOT LISTED 508NO 510(K)	New Orleans District Office (NOL-DO)
9/27/2013	75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER	118NOT LISTED 341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
9/27/2013	75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER	118NOT LISTED 341REGISTERED	Los Angeles District Office (LOS-DO)
8/19/2013	75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER	118NOT LISTED 508NO 510(K)	Division of Southeast Imports (DSEI)
6/10/2013	75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER	3280FRNMFGREG	Los Angeles District Office (LOS-DO)
10/23/2012	75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER	341REGISTERED	Division of Southeast Imports (DSEI)
10/23/2012	75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER	341REGISTERED	Division of Southeast Imports (DSEI)
8/24/2011	75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER	16DIRECTIONS 341REGISTERED	New Orleans District Office (NOL-DO)
5/16/2011	75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER	118NOT LISTED 508NO 510(K)	San Francisco District Office (SAN-DO)
4/13/2010	75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
4/13/2010	75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
4/13/2010	75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER	118NOT LISTED 341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
6/2/2006	75LFRGLUCOSE DEHYDROGENASE, GLUCOSE	118NOT LISTED	San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is Flextronics Medical Device Manufacturing(Shenzhen) Co., Ltd.'s FDA import refusal history?

Flextronics Medical Device Manufacturing(Shenzhen) Co., Ltd. (FEI: 3004173703) has 19 FDA import refusal record(s) in our database, spanning from 6/2/2006 to 5/3/2022.

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. Flextronics Medical Device Manufacturing(Shenzhen) Co., Ltd.'s FEI number is 3004173703.

What types of violations has Flextronics Medical Device Manufacturing(Shenzhen) Co., Ltd. received?

Flextronics Medical Device Manufacturing(Shenzhen) Co., Ltd. has been cited for 5 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 Flextronics Medical Device Manufacturing(Shenzhen) Co., Ltd. come from?

All FDA import refusal data for Flextronics Medical Device Manufacturing(Shenzhen) 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.