SINERGIA SADELCO

⚠️ High Risk

FEI: 3023999050 • Heroica Nogales, Sonora • MEXICO

FEI

FEI Number

3023999050

📍

Location

Heroica Nogales, Sonora

🇲🇽

Country

MEXICO

🏢

Address

Calle Reforma # 496, Col. Del Rosario, Nogales, Heroica Nogales, Sonora, Mexico

High Risk

FDA Import Risk Assessment

56.6

LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

Total Refusals

Unique Violations

1/19/2023

Latest Refusal

1/19/2023

Earliest Refusal

Score Breakdown

Violation Severity

53.6×40%

Refusal Volume

57.2×30%

Recency

40.2×20%

Frequency

100.0×10%

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

Violation Summary

48233×

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.

7533×

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).

32432×

NO ENGLISH

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)).

Refusal History

Date	Product	Violations	Division
1/19/2023	36CHB04HONEY	482NUTRIT LBL	Division of Southwest Imports (DSWI)
1/19/2023	41YHT99DIETARY CONVENTIONAL FOODS, N.E.C.	324NO ENGLISH 482NUTRIT LBL 75UNAPPROVED	Division of Southwest Imports (DSWI)
1/19/2023	41YHT99DIETARY CONVENTIONAL FOODS, N.E.C.	324NO ENGLISH 482NUTRIT LBL 75UNAPPROVED	Division of Southwest Imports (DSWI)
1/19/2023	41YHT99DIETARY CONVENTIONAL FOODS, N.E.C.	324NO ENGLISH 482NUTRIT LBL 75UNAPPROVED	Division of Southwest Imports (DSWI)
1/19/2023	41YHT99DIETARY CONVENTIONAL FOODS, N.E.C.	324NO ENGLISH 482NUTRIT LBL 75UNAPPROVED	Division of Southwest Imports (DSWI)
1/19/2023	41YHT99DIETARY CONVENTIONAL FOODS, N.E.C.	324NO ENGLISH 482NUTRIT LBL 75UNAPPROVED	Division of Southwest Imports (DSWI)
1/19/2023	41YHT99DIETARY CONVENTIONAL FOODS, N.E.C.	324NO ENGLISH 482NUTRIT LBL 75UNAPPROVED	Division of Southwest Imports (DSWI)
1/19/2023	41YHT99DIETARY CONVENTIONAL FOODS, N.E.C.	324NO ENGLISH 482NUTRIT LBL 75UNAPPROVED	Division of Southwest Imports (DSWI)
1/19/2023	41YHT99DIETARY CONVENTIONAL FOODS, N.E.C.	324NO ENGLISH 482NUTRIT LBL 75UNAPPROVED	Division of Southwest Imports (DSWI)
1/19/2023	41YHT99DIETARY CONVENTIONAL FOODS, N.E.C.	324NO ENGLISH 482NUTRIT LBL 75UNAPPROVED	Division of Southwest Imports (DSWI)
1/19/2023	41YHT99DIETARY CONVENTIONAL FOODS, N.E.C.	324NO ENGLISH 482NUTRIT LBL 75UNAPPROVED	Division of Southwest Imports (DSWI)
1/19/2023	41YHT99DIETARY CONVENTIONAL FOODS, N.E.C.	324NO ENGLISH 482NUTRIT LBL 75UNAPPROVED	Division of Southwest Imports (DSWI)
1/19/2023	41YHT99DIETARY CONVENTIONAL FOODS, N.E.C.	324NO ENGLISH 482NUTRIT LBL 75UNAPPROVED	Division of Southwest Imports (DSWI)
1/19/2023	41YHT99DIETARY CONVENTIONAL FOODS, N.E.C.	324NO ENGLISH 482NUTRIT LBL 75UNAPPROVED	Division of Southwest Imports (DSWI)
1/19/2023	41YHT99DIETARY CONVENTIONAL FOODS, N.E.C.	324NO ENGLISH 482NUTRIT LBL 75UNAPPROVED	Division of Southwest Imports (DSWI)
1/19/2023	41YHT99DIETARY CONVENTIONAL FOODS, N.E.C.	324NO ENGLISH 482NUTRIT LBL 75UNAPPROVED	Division of Southwest Imports (DSWI)
1/19/2023	41YHT99DIETARY CONVENTIONAL FOODS, N.E.C.	324NO ENGLISH 482NUTRIT LBL 75UNAPPROVED	Division of Southwest Imports (DSWI)
1/19/2023	41YHT99DIETARY CONVENTIONAL FOODS, N.E.C.	324NO ENGLISH 482NUTRIT LBL 75UNAPPROVED	Division of Southwest Imports (DSWI)
1/19/2023	41YHT99DIETARY CONVENTIONAL FOODS, N.E.C.	324NO ENGLISH 482NUTRIT LBL 75UNAPPROVED	Division of Southwest Imports (DSWI)
1/19/2023	41YHT99DIETARY CONVENTIONAL FOODS, N.E.C.	324NO ENGLISH 482NUTRIT LBL 75UNAPPROVED	Division of Southwest Imports (DSWI)
1/19/2023	41YHT99DIETARY CONVENTIONAL FOODS, N.E.C.	324NO ENGLISH 482NUTRIT LBL 75UNAPPROVED	Division of Southwest Imports (DSWI)
1/19/2023	41YHT99DIETARY CONVENTIONAL FOODS, N.E.C.	324NO ENGLISH 482NUTRIT LBL 75UNAPPROVED	Division of Southwest Imports (DSWI)
1/19/2023	41YHT99DIETARY CONVENTIONAL FOODS, N.E.C.	324NO ENGLISH 482NUTRIT LBL 75UNAPPROVED	Division of Southwest Imports (DSWI)
1/19/2023	41YHT99DIETARY CONVENTIONAL FOODS, N.E.C.	324NO ENGLISH 482NUTRIT LBL 75UNAPPROVED	Division of Southwest Imports (DSWI)
1/19/2023	41YHT99DIETARY CONVENTIONAL FOODS, N.E.C.	324NO ENGLISH 482NUTRIT LBL 75UNAPPROVED	Division of Southwest Imports (DSWI)
1/19/2023	41GHT99MEDICAL FOODS, N.E.C.	324NO ENGLISH 482NUTRIT LBL 75UNAPPROVED	Division of Southwest Imports (DSWI)
1/19/2023	41YHT99DIETARY CONVENTIONAL FOODS, N.E.C.	324NO ENGLISH 482NUTRIT LBL 75UNAPPROVED	Division of Southwest Imports (DSWI)
1/19/2023	41YHT99DIETARY CONVENTIONAL FOODS, N.E.C.	324NO ENGLISH 482NUTRIT LBL 75UNAPPROVED	Division of Southwest Imports (DSWI)
1/19/2023	41YHT99DIETARY CONVENTIONAL FOODS, N.E.C.	324NO ENGLISH 482NUTRIT LBL 75UNAPPROVED	Division of Southwest Imports (DSWI)
1/19/2023	41YHT99DIETARY CONVENTIONAL FOODS, N.E.C.	324NO ENGLISH 482NUTRIT LBL 75UNAPPROVED	Division of Southwest Imports (DSWI)
1/19/2023	41YHT99DIETARY CONVENTIONAL FOODS, N.E.C.	324NO ENGLISH 482NUTRIT LBL 75UNAPPROVED	Division of Southwest Imports (DSWI)
1/19/2023	41YHT99DIETARY CONVENTIONAL FOODS, N.E.C.	324NO ENGLISH 482NUTRIT LBL 75UNAPPROVED	Division of Southwest Imports (DSWI)
1/19/2023	41YHT99DIETARY CONVENTIONAL FOODS, N.E.C.	324NO ENGLISH 482NUTRIT LBL 75UNAPPROVED	Division of Southwest Imports (DSWI)
1/19/2023	53BD99OTHER BATH PREPARATIONS, N.E.C.	75UNAPPROVED	Division of Southwest Imports (DSWI)

Frequently Asked Questions

What is SINERGIA SADELCO's FDA import refusal history?

SINERGIA SADELCO (FEI: 3023999050) has 34 FDA import refusal record(s) in our database, spanning from 1/19/2023 to 1/19/2023.

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. SINERGIA SADELCO's FEI number is 3023999050.

What types of violations has SINERGIA SADELCO received?

SINERGIA SADELCO 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 SINERGIA SADELCO come from?

All FDA import refusal data for SINERGIA SADELCO 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.