Productora y Comercializadora Sphenarium S.A. de C.V.
⚠️ Moderate Risk
FEI: 3027240903 • Santa Maria Coyotepec, Oaxaca • MEXICO
FEI Number
3027240903
Location
Santa Maria Coyotepec, Oaxaca
Country
MEXICOAddress
Libertad S/N Santa Maria Coyotepec, , Santa Maria Coyotepec, Oaxaca, Mexico
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
COLOR LBLG
The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.
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)).
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.
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)).
POISONOUS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. Contains:
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/8/2023 | 42QCT99EDIBLE INSECT SALTS AND SPICES, N.E.C. | Division of Southwest Imports (DSWI) | |
| 1/19/2023 | 42QCT99EDIBLE INSECT SALTS AND SPICES, N.E.C. | Division of Southwest Imports (DSWI) | |
| 6/13/2022 | 42QCT99EDIBLE INSECT SALTS AND SPICES, N.E.C. | Division of Southwest Imports (DSWI) | |
| 6/13/2022 | 42QCT99EDIBLE INSECT SALTS AND SPICES, N.E.C. | Division of Southwest Imports (DSWI) | |
| 10/25/2021 | 42QGT01EDIBLE INSECT SALTS | Division of Southwest Imports (DSWI) | |
| 4/16/2021 | 42QVT01EDIBLE INSECT SALTS | Division of Southwest Imports (DSWI) | |
| 4/16/2021 | 42QCT01EDIBLE INSECT SALTS | Division of Southwest Imports (DSWI) | |
| 7/6/2018 | 42QGT99EDIBLE INSECT SALTS AND SPICES, N.E.C. | 11UNSAFE COL | Division of Southwest Imports (DSWI) |
| 7/6/2018 | 42QGT99EDIBLE INSECT SALTS AND SPICES, N.E.C. | 11UNSAFE COL | Division of Southwest Imports (DSWI) |
| 7/6/2018 | 42QGT99EDIBLE INSECT SALTS AND SPICES, N.E.C. | 11UNSAFE COL | Division of Southwest Imports (DSWI) |
| 11/20/2017 | 42QCT01EDIBLE INSECT SALTS | Division of Southwest Imports (DSWI) | |
| 11/20/2017 | 42QCT01EDIBLE INSECT SALTS | Division of Southwest Imports (DSWI) | |
| 9/16/2016 | 42QCT99EDIBLE INSECT SALTS AND SPICES, N.E.C. | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is Productora y Comercializadora Sphenarium S.A. de C.V.'s FDA import refusal history?
Productora y Comercializadora Sphenarium S.A. de C.V. (FEI: 3027240903) has 13 FDA import refusal record(s) in our database, spanning from 9/16/2016 to 2/8/2023.
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. Productora y Comercializadora Sphenarium S.A. de C.V.'s FEI number is 3027240903.
What types of violations has Productora y Comercializadora Sphenarium S.A. de C.V. received?
Productora y Comercializadora Sphenarium S.A. de C.V. has been cited for 7 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 Productora y Comercializadora Sphenarium S.A. de C.V. come from?
All FDA import refusal data for Productora y Comercializadora Sphenarium S.A. de C.V. 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.