MIYAQUIL SA
⚠️ High Risk
FEI: 3011288973 • Guayaquil, Guayas • ECUADOR
FEI Number
3011288973
Location
Guayaquil, Guayas
Country
ECUADORAddress
Venezuela 4507 y 16, , Guayaquil, Guayas, Ecuador
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
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).
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:
UNSFDIETLB
The article appears to be a dietary supplement or contain a dietary ingredient that presents a significant or unreasonable risk of illness or injury under the conditions of use set out in the labeling or, if none are set out in the labeling, under customary conditions of use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/28/2012 | 54FCL07COMFREY (HERBAL & BOTANICALS, NOT TEAS) | 2460UNSFDIETLB | New York District Office (NYK-DO) |
| 6/25/2012 | 24FGT50TOMATOES (FRUIT USED AS VEGETABLE) | 3721PESTICIDE2 | Division of Northeast Imports (DNEI) |
| 6/25/2012 | 24FGT50TOMATOES (FRUIT USED AS VEGETABLE) | 3721PESTICIDE2 | Division of Northeast Imports (DNEI) |
| 4/2/2010 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 4/2/2010 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 4/2/2010 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 4/2/2010 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 4/2/2010 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 4/2/2010 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 4/2/2010 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 4/2/2010 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 4/2/2010 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 4/2/2010 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 4/2/2010 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 4/2/2010 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 4/2/2010 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 4/2/2010 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 4/2/2010 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 4/2/2010 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 4/2/2010 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 4/2/2010 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 4/2/2010 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 4/2/2010 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 4/2/2010 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 4/2/2010 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 4/2/2010 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 4/2/2010 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 4/2/2010 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 4/2/2010 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 4/2/2010 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 4/2/2010 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 4/2/2010 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is MIYAQUIL SA's FDA import refusal history?
MIYAQUIL SA (FEI: 3011288973) has 32 FDA import refusal record(s) in our database, spanning from 4/2/2010 to 11/28/2012.
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. MIYAQUIL SA's FEI number is 3011288973.
What types of violations has MIYAQUIL SA received?
MIYAQUIL SA 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 MIYAQUIL SA come from?
All FDA import refusal data for MIYAQUIL SA 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.