Broncolin, S.A. de C.V.
⚠️ Moderate Risk
FEI: 3006574162 • Ciudad De Mexico, Ciudad de Mexico • MEXICO
FEI Number
3006574162
Location
Ciudad De Mexico, Ciudad de Mexico
Country
MEXICOAddress
Calle Manuel Avila Camacho No. 44, Col. Santa Maria Aztahuacan, Iztapalapa, 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
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 |
|---|---|---|---|
| 3/30/2009 | 62MBY08MENTHOL (ANTI-PRURITIC) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 3/30/2009 | 62MBY08MENTHOL (ANTI-PRURITIC) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 3/30/2009 | 62MBY08MENTHOL (ANTI-PRURITIC) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Broncolin, S.A. de C.V.'s FDA import refusal history?
Broncolin, S.A. de C.V. (FEI: 3006574162) has 3 FDA import refusal record(s) in our database, spanning from 3/30/2009 to 3/30/2009.
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. Broncolin, S.A. de C.V.'s FEI number is 3006574162.
What types of violations has Broncolin, S.A. de C.V. received?
Broncolin, 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 Broncolin, S.A. de C.V. come from?
All FDA import refusal data for Broncolin, 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.