Intradevco Industrial S.A
⚠️ Moderate Risk
FEI: 3008389499 • Chorillos • PERU
FEI Number
3008389499
Location
Chorillos
Country
PERUAddress
Av Produccion Nacional 188, , Chorillos, , Peru
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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
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 |
|---|---|---|---|
| 9/14/2010 | 62WAQ17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | Florida District Office (FLA-DO) | |
| 9/14/2010 | 62WAQ17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | Florida District Office (FLA-DO) | |
| 9/14/2010 | 61HAL99ANTI-BACTERIAL, N.E.C. | Florida District Office (FLA-DO) | |
| 9/14/2010 | 66PNJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Florida District Office (FLA-DO) | |
| 9/14/2010 | 66PNJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Florida District Office (FLA-DO) | |
| 9/14/2010 | 62WAL17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | Florida District Office (FLA-DO) | |
| 9/14/2010 | 62WAL17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Intradevco Industrial S.A's FDA import refusal history?
Intradevco Industrial S.A (FEI: 3008389499) has 7 FDA import refusal record(s) in our database, spanning from 9/14/2010 to 9/14/2010.
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. Intradevco Industrial S.A's FEI number is 3008389499.
What types of violations has Intradevco Industrial S.A received?
Intradevco Industrial S.A 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 Intradevco Industrial S.A come from?
All FDA import refusal data for Intradevco Industrial S.A 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.