ORCO INTERNATIONAL S.A.
⚠️ Moderate Risk
FEI: 3004307259 • San Isidro, Lima • PERU
FEI Number
3004307259
Location
San Isidro, Lima
Country
PERUAddress
Of. 202, Calle Mariano De Los Santos 183, San Isidro, Lima, 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
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/28/2005 | 16EEE02CLAMS | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is ORCO INTERNATIONAL S.A.'s FDA import refusal history?
ORCO INTERNATIONAL S.A. (FEI: 3004307259) has 1 FDA import refusal record(s) in our database, spanning from 7/28/2005 to 7/28/2005.
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. ORCO INTERNATIONAL S.A.'s FEI number is 3004307259.
What types of violations has ORCO INTERNATIONAL S.A. received?
ORCO INTERNATIONAL S.A. has been cited for 1 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 ORCO INTERNATIONAL S.A. come from?
All FDA import refusal data for ORCO INTERNATIONAL 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.