Santa Terezinha Distribuidora de Produtos Industrializados
⚠️ High Risk
FEI: 3004274197 • Contagem, Minas Gerais • BRAZIL
FEI Number
3004274197
Location
Contagem, Minas Gerais
Country
BRAZILAddress
Via Manoel Jacinto Coelho Junior, 901, , Contagem, Minas Gerais, Brazil
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
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).
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.
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).
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 |
|---|---|---|---|
| 8/9/2004 | 24FGT04PIMIENTO PEPPER (FRUIT USED AS VEGETABLE) | Florida District Office (FLA-DO) | |
| 8/9/2004 | 09AFO01BUTTER (PLAIN OR WHIPPED) | Florida District Office (FLA-DO) | |
| 8/9/2004 | 16AET33SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.) | Florida District Office (FLA-DO) | |
| 8/9/2004 | 21WET03FIG, TOPPING OR SYRUP | Florida District Office (FLA-DO) | |
| 8/9/2004 | 21IGT15PRUNES (DRIED PLUMS) (PIT FRUIT PUREES) | Florida District Office (FLA-DO) | |
| 6/10/2004 | 53UD12SKIN CARE PREPARATIONS, COSMETIC PRODUCTS CONTAINING ANIMAL BY-PRODUCTS (OTHER ANIMAL BY-PRODUCTS) | Division of Southeast Imports (DSEI) | |
| 6/10/2004 | 21WFC03FIG, TOPPING OR SYRUP | Division of Southeast Imports (DSEI) | |
| 9/17/2003 | 25YAE99VEGETABLE & VEGETABLE PRODUCTS NOT MENTIONED ELSEWHERE, N.E.C. | Florida District Office (FLA-DO) | |
| 9/17/2003 | 30YEF02COCONUT MILK BEVERAGE BASE | Florida District Office (FLA-DO) | |
| 8/25/2003 | 66PB99ULTRAVIOLET SCREEN N.E.C. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 8/25/2003 | 53IA01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 8/25/2003 | 55RP70BORIC ACID (PHARMACEUTIC NECESSITY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/25/2003 | 25YAE99VEGETABLE & VEGETABLE PRODUCTS NOT MENTIONED ELSEWHERE, N.E.C. | Division of Southeast Imports (DSEI) | |
| 8/25/2003 | 05YAE99CEREAL PREPARATIONS NOT ELSEWHERE MENTIONED, N.E.C. | Division of Southeast Imports (DSEI) | |
| 8/25/2003 | 21WAC03FIG, TOPPING OR SYRUP | Division of Southeast Imports (DSEI) | |
| 8/25/2003 | 21GCP09OLIVES (PIT FRUIT) | Division of Southeast Imports (DSEI) | |
| 8/25/2003 | 29AAC99NONCARBONATED SOFT DRINK, N.E.C. | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Santa Terezinha Distribuidora de Produtos Industrializados's FDA import refusal history?
Santa Terezinha Distribuidora de Produtos Industrializados (FEI: 3004274197) has 17 FDA import refusal record(s) in our database, spanning from 8/25/2003 to 8/9/2004.
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. Santa Terezinha Distribuidora de Produtos Industrializados's FEI number is 3004274197.
What types of violations has Santa Terezinha Distribuidora de Produtos Industrializados received?
Santa Terezinha Distribuidora de Produtos Industrializados has been cited for 5 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 Santa Terezinha Distribuidora de Produtos Industrializados come from?
All FDA import refusal data for Santa Terezinha Distribuidora de Produtos Industrializados 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.