Gmo Covarrubias
⚠️ Moderate Risk
FEI: 3003483995 • Ciudad De Mexico, Ciudad de Mexico • MEXICO
FEI Number
3003483995
Location
Ciudad De Mexico, Ciudad de Mexico
Country
MEXICOAddress
Calle Playa Tecolutla 414, Col. Reforma Iztaccihuatl Sur, Iztacalco, Ciudad De Mexico, Ciudad de Mexico, Mexico
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
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
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 |
|---|---|---|---|
| 6/20/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 179AGR RX | New Orleans District Office (NOL-DO) |
| 6/20/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 179AGR RX | New Orleans District Office (NOL-DO) |
| 6/20/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 179AGR RX | New Orleans District Office (NOL-DO) |
| 6/20/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 179AGR RX | New Orleans District Office (NOL-DO) |
| 6/20/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/20/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/20/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Gmo Covarrubias's FDA import refusal history?
Gmo Covarrubias (FEI: 3003483995) has 7 FDA import refusal record(s) in our database, spanning from 6/20/2002 to 6/20/2002.
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. Gmo Covarrubias's FEI number is 3003483995.
What types of violations has Gmo Covarrubias received?
Gmo Covarrubias has been cited for 2 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 Gmo Covarrubias come from?
All FDA import refusal data for Gmo Covarrubias 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.