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JOSE FRANCISCO RAMOS FERNANDES

⚠️ Moderate Risk

FEI: 3012321232 • Sao Paulo • BRAZIL

FEI

FEI Number

3012321232

📍

Location

Sao Paulo

🇧🇷

Country

BRAZIL
🏢

Address

Rua Jose Gabriel Rachid, , Sao Paulo, , Brazil

Moderate Risk

FDA Import Risk Assessment

29.7
LowModerateHighCritical

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

Statistics

2
Total Refusals
3
Unique Violations
11/15/2017
Latest Refusal
11/15/2017
Earliest Refusal

Score Breakdown

Violation Severity
56.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

3202×

LACKS FIRM

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.

752×

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).

38641×

NCONTACT

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.

Refusal History

DateProductViolationsDivision
11/15/2017
54FCL99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
320LACKS FIRM
3864NCONTACT
75UNAPPROVED
Division of Southeast Imports (DSEI)
11/15/2017
54FCL99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
320LACKS FIRM
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is JOSE FRANCISCO RAMOS FERNANDES's FDA import refusal history?

JOSE FRANCISCO RAMOS FERNANDES (FEI: 3012321232) has 2 FDA import refusal record(s) in our database, spanning from 11/15/2017 to 11/15/2017.

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. JOSE FRANCISCO RAMOS FERNANDES's FEI number is 3012321232.

What types of violations has JOSE FRANCISCO RAMOS FERNANDES received?

JOSE FRANCISCO RAMOS FERNANDES has been cited for 3 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 JOSE FRANCISCO RAMOS FERNANDES come from?

All FDA import refusal data for JOSE FRANCISCO RAMOS FERNANDES 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.