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SHANGHAI F & L

Low Risk

FEI: 3015962342 • Shanghai • CHINA

FEI

FEI Number

3015962342

📍

Location

Shanghai

🇨🇳

Country

CHINA
🏢

Address

No. 1318 Lixue Road #3, , Shanghai, , 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
5
Unique Violations
2/19/2020
Latest Refusal
2/19/2020
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).

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.

3361×

INCONSPICU

Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

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
2/19/2020
64GIZ19ETHINYL ESTRADIOL (ESTROGEN)
118NOT LISTED
333LACKS FIRM
336INCONSPICU
483DRUG NAME
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is SHANGHAI F & L's FDA import refusal history?

SHANGHAI F & L (FEI: 3015962342) has 1 FDA import refusal record(s) in our database, spanning from 2/19/2020 to 2/19/2020.

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. SHANGHAI F & L's FEI number is 3015962342.

What types of violations has SHANGHAI F & L received?

SHANGHAI F & L 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 SHANGHAI F & L come from?

All FDA import refusal data for SHANGHAI F & L 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.