Productos Quimicos Naturales S.A de C.V
⚠️ Moderate Risk
FEI: 3002807925 • Ixtaczoquitlan, Veracruz • MEXICO
FEI Number
3002807925
Location
Ixtaczoquitlan, Veracruz
Country
MEXICOAddress
Av. Reforma No. 46, Potrerillo, , Ixtaczoquitlan, Veracruz, 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
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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).
RX LEGEND
The article appears to be a prescription drug without a prescription drug legend as required by Section 503(b)(4).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/22/2016 | 60NCZ99ANDROGEN, N.E.C. | Baltimore District Office (BLT-DO) | |
| 7/26/2016 | 60NCS14TESTOSTERONE (ANDROGEN) | Division of Southwest Imports (DSWI) | |
| 6/6/2002 | 60NIS14TESTOSTERONE (ANDROGEN) | 16DIRECTIONS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Productos Quimicos Naturales S.A de C.V's FDA import refusal history?
Productos Quimicos Naturales S.A de C.V (FEI: 3002807925) has 3 FDA import refusal record(s) in our database, spanning from 6/6/2002 to 8/22/2016.
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. Productos Quimicos Naturales S.A de C.V's FEI number is 3002807925.
What types of violations has Productos Quimicos Naturales S.A de C.V received?
Productos Quimicos Naturales S.A de C.V has been cited for 4 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 Productos Quimicos Naturales S.A de C.V come from?
All FDA import refusal data for Productos Quimicos Naturales 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.