Industrias Quimicas Y Farmaceuticas
⚠️ Moderate Risk
FEI: 3001431824 • Santo Domingo • DOMINICAN REPUBLIC
FEI Number
3001431824
Location
Santo Domingo
Country
DOMINICAN REPUBLICAddress
Carret Manoguayabo Km. 2.5, , Santo Domingo, , Dominican Republic
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
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.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/8/2003 | 54YMA99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 473LABELING | San Juan District Office (SJN-DO) |
| 2/8/2003 | 54YMA99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 218LIST INGRE | San Juan District Office (SJN-DO) |
| 4/3/2002 | 54YMA99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 218LIST INGRE | San Juan District Office (SJN-DO) |
| 4/3/2002 | 54YMA99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 218LIST INGRE | San Juan District Office (SJN-DO) |
| 4/3/2002 | 54YMA99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 218LIST INGRE | San Juan District Office (SJN-DO) |
| 4/3/2002 | 54YMA99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 218LIST INGRE | San Juan District Office (SJN-DO) |
| 4/3/2002 | 54YMA99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 218LIST INGRE | San Juan District Office (SJN-DO) |
| 4/3/2002 | 54YMA99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 218LIST INGRE | San Juan District Office (SJN-DO) |
| 4/3/2002 | 54YMA99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 218LIST INGRE | San Juan District Office (SJN-DO) |
| 1/25/2002 | 68YYY20ANIMAL DRUGS N.E.C. USED MORE THAN 1 SPECIES | San Juan District Office (SJN-DO) |
Frequently Asked Questions
What is Industrias Quimicas Y Farmaceuticas's FDA import refusal history?
Industrias Quimicas Y Farmaceuticas (FEI: 3001431824) has 10 FDA import refusal record(s) in our database, spanning from 1/25/2002 to 2/8/2003.
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. Industrias Quimicas Y Farmaceuticas's FEI number is 3001431824.
What types of violations has Industrias Quimicas Y Farmaceuticas received?
Industrias Quimicas Y Farmaceuticas 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 Industrias Quimicas Y Farmaceuticas come from?
All FDA import refusal data for Industrias Quimicas Y Farmaceuticas 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.