South-Am Freeze Dry S.A.
⚠️ High Risk
FEI: 3006153209 • Vitacura, FN • CHILE
FEI Number
3006153209
Location
Vitacura, FN
Country
CHILEAddress
Avenida Vitacura 4380, Of 52, , Vitacura, FN, Chile
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
PESTICIDE2
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be adulterated because it contains a pesticide chemical, which is in violation of section 402(a)(2)(B). Contains:
PESTICIDES
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be adulterated because it contains a pesticide chemical, which is in violation of section 402(a)(2)(B). Contains:
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/25/2014 | 20BYH99BERRIES, DRIED OR PASTE, N.E.C. | 3721PESTICIDE2 | Chicago District Office (CHI-DO) |
| 8/25/2014 | 20BYH99BERRIES, DRIED OR PASTE, N.E.C. | 3721PESTICIDE2 | Chicago District Office (CHI-DO) |
| 4/16/2014 | 20BGH14STRAWBERRIES, DRIED OR PASTE | 3721PESTICIDE2 | Minneapolis District Office (MIN-DO) |
| 10/29/2013 | 20BGH99BERRIES, DRIED OR PASTE, N.E.C. | 3721PESTICIDE2 | Southwest Import District Office (SWI-DO) |
| 10/25/2012 | 20BGT14STRAWBERRIES, DRIED OR PASTE | 3721PESTICIDE2 | Los Angeles District Office (LOS-DO) |
| 10/25/2012 | 20BGT14STRAWBERRIES, DRIED OR PASTE | 3721PESTICIDE2 | Los Angeles District Office (LOS-DO) |
| 10/25/2012 | 20BGT99BERRIES, DRIED OR PASTE, N.E.C. | 3721PESTICIDE2 | Los Angeles District Office (LOS-DO) |
| 10/25/2012 | 20BGT99BERRIES, DRIED OR PASTE, N.E.C. | 3721PESTICIDE2 | Los Angeles District Office (LOS-DO) |
| 9/4/2012 | 54YBR99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | San Francisco District Office (SAN-DO) |
| 5/24/2012 | 20BGH99BERRIES, DRIED OR PASTE, N.E.C. | 3721PESTICIDE2 | Chicago District Office (CHI-DO) |
| 7/6/2011 | 20BGH99BERRIES, DRIED OR PASTE, N.E.C. | 2920PESTICIDES | New York District Office (NYK-DO) |
| 5/31/2011 | 20BGH99BERRIES, DRIED OR PASTE, N.E.C. | 2920PESTICIDES | New York District Office (NYK-DO) |
| 12/14/2010 | 20BGH99BERRIES, DRIED OR PASTE, N.E.C. | 2920PESTICIDES | New York District Office (NYK-DO) |
Frequently Asked Questions
What is South-Am Freeze Dry S.A.'s FDA import refusal history?
South-Am Freeze Dry S.A. (FEI: 3006153209) has 13 FDA import refusal record(s) in our database, spanning from 12/14/2010 to 8/25/2014.
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. South-Am Freeze Dry S.A.'s FEI number is 3006153209.
What types of violations has South-Am Freeze Dry S.A. received?
South-Am Freeze Dry 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 South-Am Freeze Dry S.A. come from?
All FDA import refusal data for South-Am Freeze Dry 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.