RFX+CARE Manufacturing Co., Ltd.

⚠️ Moderate Risk

FEI: 3007307589 • Shaoxing, Zhejiang • CHINA

FEI

FEI Number

3007307589

📍

Location

Shaoxing, Zhejiang

🇨🇳

Country

CHINA

🏢

Address

7 Lanjiang Road, Yuecheng, Shaoxing, Zhejiang, China

Moderate Risk

FDA Import Risk Assessment

35.1

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

3/4/2020

Latest Refusal

12/12/2013

Earliest Refusal

Score Breakdown

Violation Severity

37.5×40%

Refusal Volume

53.0×30%

Recency

0.0×20%

Frequency

41.7×10%

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

47315×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

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.

32604×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)

1181×

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).

Refusal History

Date	Product	Violations	Division
3/4/2020	79OHOFIRST AID KIT WITHOUT DRUG	118NOT LISTED 3280FRNMFGREG 341REGISTERED	Division of Northern Border Imports (DNBI)
2/15/2017	79KGXTAPE AND BANDAGE, ADHESIVE	3260NO ENGLISH 3280FRNMFGREG 341REGISTERED	Division of Northeast Imports (DNEI)
2/15/2017	79KGXTAPE AND BANDAGE, ADHESIVE	3260NO ENGLISH 3280FRNMFGREG 341REGISTERED	Division of Northeast Imports (DNEI)
2/15/2017	79KGXTAPE AND BANDAGE, ADHESIVE	3260NO ENGLISH 3280FRNMFGREG 341REGISTERED	Division of Northeast Imports (DNEI)
2/15/2017	79KGXTAPE AND BANDAGE, ADHESIVE	3260NO ENGLISH 3280FRNMFGREG 341REGISTERED	Division of Northeast Imports (DNEI)
2/15/2017	79KGXTAPE AND BANDAGE, ADHESIVE	473LABELING	Division of Northeast Imports (DNEI)
2/15/2017	79KGXTAPE AND BANDAGE, ADHESIVE	473LABELING	Division of Northeast Imports (DNEI)
2/15/2017	79KGXTAPE AND BANDAGE, ADHESIVE	473LABELING	Division of Northeast Imports (DNEI)
2/15/2017	79KGXTAPE AND BANDAGE, ADHESIVE	473LABELING	Division of Northeast Imports (DNEI)
2/15/2017	79KGXTAPE AND BANDAGE, ADHESIVE	473LABELING	Division of Northeast Imports (DNEI)
2/15/2017	79KGXTAPE AND BANDAGE, ADHESIVE	473LABELING	Division of Northeast Imports (DNEI)
2/15/2017	79KGXTAPE AND BANDAGE, ADHESIVE	473LABELING	Division of Northeast Imports (DNEI)
2/15/2017	79KGXTAPE AND BANDAGE, ADHESIVE	473LABELING	Division of Northeast Imports (DNEI)
2/15/2017	79KGXTAPE AND BANDAGE, ADHESIVE	473LABELING	Division of Northeast Imports (DNEI)
2/15/2017	79KGXTAPE AND BANDAGE, ADHESIVE	473LABELING	Division of Northeast Imports (DNEI)
2/15/2017	79KGXTAPE AND BANDAGE, ADHESIVE	473LABELING	Division of Northeast Imports (DNEI)
2/15/2017	79KGXTAPE AND BANDAGE, ADHESIVE	473LABELING	Division of Northeast Imports (DNEI)
2/15/2017	79KGXTAPE AND BANDAGE, ADHESIVE	473LABELING	Division of Northeast Imports (DNEI)
2/15/2017	79KGXTAPE AND BANDAGE, ADHESIVE	473LABELING	Division of Northeast Imports (DNEI)
2/15/2017	79KGXTAPE AND BANDAGE, ADHESIVE	473LABELING	Division of Northeast Imports (DNEI)
4/7/2014	80KGXTAPE AND BANDAGE, ADHESIVE	341REGISTERED	Los Angeles District Office (LOS-DO)
4/7/2014	80KGXTAPE AND BANDAGE, ADHESIVE	341REGISTERED	Los Angeles District Office (LOS-DO)
4/7/2014	80KGXTAPE AND BANDAGE, ADHESIVE	341REGISTERED	Los Angeles District Office (LOS-DO)
12/12/2013	80KGXTAPE AND BANDAGE, ADHESIVE	341REGISTERED	Baltimore District Office (BLT-DO)
12/12/2013	80KGXTAPE AND BANDAGE, ADHESIVE	341REGISTERED	Baltimore District Office (BLT-DO)
12/12/2013	80KGXTAPE AND BANDAGE, ADHESIVE	341REGISTERED	Baltimore District Office (BLT-DO)

Frequently Asked Questions

What is RFX+CARE Manufacturing Co., Ltd.'s FDA import refusal history?

RFX+CARE Manufacturing Co., Ltd. (FEI: 3007307589) has 26 FDA import refusal record(s) in our database, spanning from 12/12/2013 to 3/4/2020.

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. RFX+CARE Manufacturing Co., Ltd.'s FEI number is 3007307589.

What types of violations has RFX+CARE Manufacturing Co., Ltd. received?

RFX+CARE Manufacturing 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 RFX+CARE Manufacturing Co., Ltd. come from?

All FDA import refusal data for RFX+CARE Manufacturing 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.