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Bristro John M.Squibb

⚠️ Moderate Risk

FEI: 3004058612 • Ciudad Delicias, CHI • MEXICO

FEI

FEI Number

3004058612

📍

Location

Ciudad Delicias, CHI

🇲🇽

Country

MEXICO
🏢

Address

Panamericana Km.1573, , Ciudad Delicias, CHI, Mexico

Moderate Risk

FDA Import Risk Assessment

25.1
LowModerateHighCritical

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

Statistics

4
Total Refusals
3
Unique Violations
3/23/2007
Latest Refusal
4/2/2004
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
13.5×10%
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

4823×

NUTRIT LBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.

2561×

INCONSPICU

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(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).

2601×

FALSE

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(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.

Refusal History

DateProductViolationsDivision
3/23/2007
34BET99CHOCOLATE AND COCOA, N.E.C.
482NUTRIT LBL
Southwest Import District Office (SWI-DO)
11/22/2006
41EET99MEAL REPLACEMENTS (NOT LABELED FOR TREATMENT OF DISEASE)
260FALSE
482NUTRIT LBL
Southwest Import District Office (SWI-DO)
11/17/2004
34BET99CHOCOLATE AND COCOA, N.E.C.
482NUTRIT LBL
Southwest Import District Office (SWI-DO)
4/2/2004
41EMT99MEAL REPLACEMENTS (NOT LABELED FOR TREATMENT OF DISEASE)
256INCONSPICU
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Bristro John M.Squibb's FDA import refusal history?

Bristro John M.Squibb (FEI: 3004058612) has 4 FDA import refusal record(s) in our database, spanning from 4/2/2004 to 3/23/2007.

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. Bristro John M.Squibb's FEI number is 3004058612.

What types of violations has Bristro John M.Squibb received?

Bristro John M.Squibb 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 Bristro John M.Squibb come from?

All FDA import refusal data for Bristro John M.Squibb 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.