Promotora De Productos Mexicanos, S.A. De C.V.
⚠️ Moderate Risk
FEI: 3005304547 • San Pedro Garza Garcia • MEXICO
FEI Number
3005304547
Location
San Pedro Garza Garcia
Country
MEXICOAddress
Lazaro Cardenas 2400 C-11col., , San Pedro Garza Garcia, , 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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/7/2006 | 62WBY17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | Southwest Import District Office (SWI-DO) | |
| 7/7/2006 | 62WBY17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | Southwest Import District Office (SWI-DO) | |
| 7/7/2006 | 62WBY17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Promotora De Productos Mexicanos, S.A. De C.V.'s FDA import refusal history?
Promotora De Productos Mexicanos, S.A. De C.V. (FEI: 3005304547) has 3 FDA import refusal record(s) in our database, spanning from 7/7/2006 to 7/7/2006.
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. Promotora De Productos Mexicanos, S.A. De C.V.'s FEI number is 3005304547.
What types of violations has Promotora De Productos Mexicanos, S.A. De C.V. received?
Promotora De Productos Mexicanos, S.A. De C.V. has been cited for 2 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 Promotora De Productos Mexicanos, S.A. De C.V. come from?
All FDA import refusal data for Promotora De Productos Mexicanos, 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.