Laboratorios Voam, S.A. De C.V.
⚠️ Moderate Risk
FEI: 3003097031 • Hidalgo Del Parral, Chihuahua • MEXICO
FEI Number
3003097031
Location
Hidalgo Del Parral, Chihuahua
Country
MEXICOAddress
Calle Plazuela Morelos # 31, Col. CENTRO, Hidalgo Del Parral, Chihuahua, 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
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/5/2006 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 8/24/2005 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 12/18/2002 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 473LABELING | Southwest Import District Office (SWI-DO) |
| 5/7/2002 | 66VIJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Laboratorios Voam, S.A. De C.V.'s FDA import refusal history?
Laboratorios Voam, S.A. De C.V. (FEI: 3003097031) has 4 FDA import refusal record(s) in our database, spanning from 5/7/2002 to 4/5/2006.
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. Laboratorios Voam, S.A. De C.V.'s FEI number is 3003097031.
What types of violations has Laboratorios Voam, S.A. De C.V. received?
Laboratorios Voam, S.A. De C.V. 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 Laboratorios Voam, S.A. De C.V. come from?
All FDA import refusal data for Laboratorios Voam, 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.