Laboratorios Myryam S A De C V
⚠️ Moderate Risk
FEI: 3003870099 • Tepatitlan Jaliscomexico • MEXICO
FEI Number
3003870099
Location
Tepatitlan Jaliscomexico
Country
MEXICOAddress
Girasoles 222jardines De Tepa, , Tepatitlan Jaliscomexico, , 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).
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/30/2006 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 197COSM COLOR | Southwest Import District Office (SWI-DO) |
| 9/17/2004 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 12/9/2003 | 62SBJ99ANTI-SEBORRHEIC N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Laboratorios Myryam S A De C V's FDA import refusal history?
Laboratorios Myryam S A De C V (FEI: 3003870099) has 3 FDA import refusal record(s) in our database, spanning from 12/9/2003 to 1/30/2006.
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 Myryam S A De C V's FEI number is 3003870099.
What types of violations has Laboratorios Myryam S A De C V received?
Laboratorios Myryam S A De C V 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 Laboratorios Myryam S A De C V come from?
All FDA import refusal data for Laboratorios Myryam 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.