Universo Naturista de Mexico, S.A. de C.V.
⚠️ High Risk
FEI: 3003294401 • Morelia, MIC • MEXICO
FEI Number
3003294401
Location
Morelia, MIC
Country
MEXICOAddress
Morelos Sur 899, Col. Ventura Puente, Morelia, MIC, Mexico
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/22/2005 | 62C41MINOXIDIL (ANTI-HYPERTENSIVE) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 4/22/2005 | 62C41MINOXIDIL (ANTI-HYPERTENSIVE) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 10/15/2002 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 7/30/2002 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 7/30/2002 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 7/29/2002 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 7/29/2002 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 7/29/2002 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 7/29/2002 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 7/29/2002 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 7/29/2002 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 7/29/2002 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 7/29/2002 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 7/29/2002 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 7/29/2002 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 5/7/2002 | 66VIJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 5/7/2002 | 66VIJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 5/7/2002 | 66VIJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 4/1/2002 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 12/28/2001 | 66VIL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 12/28/2001 | 66VIL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 12/28/2001 | 66VIL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 12/28/2001 | 66VIL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 12/28/2001 | 66VIL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 12/28/2001 | 66VIJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 12/19/2001 | 66VIL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 12/19/2001 | 66VIL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Universo Naturista de Mexico, S.A. de C.V.'s FDA import refusal history?
Universo Naturista de Mexico, S.A. de C.V. (FEI: 3003294401) has 27 FDA import refusal record(s) in our database, spanning from 12/19/2001 to 4/22/2005.
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. Universo Naturista de Mexico, S.A. de C.V.'s FEI number is 3003294401.
What types of violations has Universo Naturista de Mexico, S.A. de C.V. received?
Universo Naturista de Mexico, S.A. de C.V. 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 Universo Naturista de Mexico, S.A. de C.V. come from?
All FDA import refusal data for Universo Naturista de Mexico, S.A. de C.V. 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.