Polychem S.A. de C.V.
⚠️ Moderate Risk
FEI: 3018143545 • Ciudad De Mexico, Ciudad de Mexico • MEXICO
FEI Number
3018143545
Location
Ciudad De Mexico, Ciudad de Mexico
Country
MEXICOAddress
Calle 24 De Abril De 1860 # 8, Otro Leyes De Reforma 3ra. Seccion, Iztapalapa, Ciudad De Mexico, Ciudad de Mexico, 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).
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)).
COLOR LBLG
The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.
Refusal History
Frequently Asked Questions
What is Polychem S.A. de C.V.'s FDA import refusal history?
Polychem S.A. de C.V. (FEI: 3018143545) has 1 FDA import refusal record(s) in our database, spanning from 7/30/2024 to 7/30/2024.
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. Polychem S.A. de C.V.'s FEI number is 3018143545.
What types of violations has Polychem S.A. de C.V. received?
Polychem S.A. de C.V. 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 Polychem S.A. de C.V. come from?
All FDA import refusal data for Polychem 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.