Laboratorios Bustillos S A De C V
⚠️ Moderate Risk
FEI: 3000307607 • Mexico D F Mex • MEXICO
FEI Number
3000307607
Location
Mexico D F Mex
Country
MEXICOAddress
Manuel Dublan No 40, , Mexico D F Mex, , 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/10/2003 | 63VCJ02HYDROQUINONE (DEPIGMENTOR) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 9/23/2002 | 63VCJ02HYDROQUINONE (DEPIGMENTOR) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 9/23/2002 | 66VAU99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Laboratorios Bustillos S A De C V's FDA import refusal history?
Laboratorios Bustillos S A De C V (FEI: 3000307607) has 3 FDA import refusal record(s) in our database, spanning from 9/23/2002 to 3/10/2003.
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 Bustillos S A De C V's FEI number is 3000307607.
What types of violations has Laboratorios Bustillos S A De C V received?
Laboratorios Bustillos S A De C V has been cited for 1 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 Bustillos S A De C V come from?
All FDA import refusal data for Laboratorios Bustillos 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.