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Chengdu Yabuluo Restorable Daily Necessities Co., Ltd

Low Risk

FEI: 3015962940 • Chengdu, Wuhou district • CHINA

FEI

FEI Number

3015962940

📍

Location

Chengdu, Wuhou district

🇨🇳

Country

CHINA
🏢

Address

No. 9, south street of Hongpailou Dongjiawan, , Chengdu, Wuhou district, China

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
6
Unique Violations
12/11/2019
Latest Refusal
12/11/2019
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

© ImportRefusal.com Original Analysis

Violation Summary

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).

32801×

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.

3331×

LACKS FIRM

The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.

3351×

LACKS N/C

The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.

4831×

DRUG NAME

The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.

751×

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).

Refusal History

DateProductViolationsDivision
12/11/2019
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
3280FRNMFGREG
333LACKS FIRM
335LACKS N/C
483DRUG NAME
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Chengdu Yabuluo Restorable Daily Necessities Co., Ltd's FDA import refusal history?

Chengdu Yabuluo Restorable Daily Necessities Co., Ltd (FEI: 3015962940) has 1 FDA import refusal record(s) in our database, spanning from 12/11/2019 to 12/11/2019.

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. Chengdu Yabuluo Restorable Daily Necessities Co., Ltd's FEI number is 3015962940.

What types of violations has Chengdu Yabuluo Restorable Daily Necessities Co., Ltd received?

Chengdu Yabuluo Restorable Daily Necessities 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 Chengdu Yabuluo Restorable Daily Necessities Co., Ltd come from?

All FDA import refusal data for Chengdu Yabuluo Restorable Daily Necessities 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.