BURKHARDT S.A.
⚠️ Moderate Risk
FEI: 3004662931 • Lima, Lima • PERU
FEI Number
3004662931
Location
Lima, Lima
Country
PERUAddress
Urb. El Pino. San Luis, Calle Felipe Santiago Salaverry # 275, Lima, 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.
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
LIST INGRE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
NEEDS FCE
It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/19/2011 | 21GEI09OLIVES (PIT FRUIT) | Florida District Office (FLA-DO) | |
| 6/13/2006 | 21GGT09OLIVES (PIT FRUIT) | 83NO PROCESS | Florida District Office (FLA-DO) |
| 10/11/2005 | 24FET07PEPPER, SWEET (FRUIT USED AS VEGETABLE) | 83NO PROCESS | New York District Office (NYK-DO) |
| 5/24/2005 | 25JEN99ROOT & TUBER VEGETABLE, N.E.C. | 83NO PROCESS | New York District Office (NYK-DO) |
| 4/22/2005 | 29BGT99CARBONATED SOFT DRINK, N.E.C. | 218LIST INGRE | Florida District Office (FLA-DO) |
| 4/22/2005 | 35CFE99CUSTARD PUDDING (PIE) MIX, N.E.C. | 11UNSAFE COL | Florida District Office (FLA-DO) |
| 4/22/2005 | 35CFE99CUSTARD PUDDING (PIE) MIX, N.E.C. | 11UNSAFE COL | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is BURKHARDT S.A.'s FDA import refusal history?
BURKHARDT S.A. (FEI: 3004662931) has 7 FDA import refusal record(s) in our database, spanning from 4/22/2005 to 1/19/2011.
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. BURKHARDT S.A.'s FEI number is 3004662931.
What types of violations has BURKHARDT S.A. received?
BURKHARDT S.A. 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 BURKHARDT S.A. come from?
All FDA import refusal data for BURKHARDT 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.