Bonarum Pharma Sa De Cv
⚠️ Moderate Risk
FEI: 3009177100 • Los Reyes Acaquilpan, Mexico • MEXICO
FEI Number
3009177100
Location
Los Reyes Acaquilpan, Mexico
Country
MEXICOAddress
Antigua Km 19.5, La Paz, Los Reyes Acaquilpan, 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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
DV QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/22/2011 | 86LPNACCESSORIES TO CONTACT LENSES - CLEANING AND WETTING AGENTS | Southwest Import District Office (SWI-DO) | |
| 12/22/2011 | 86LYLACCESSORIES TO CONTACT LENS SOLUTION | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Bonarum Pharma Sa De Cv's FDA import refusal history?
Bonarum Pharma Sa De Cv (FEI: 3009177100) has 2 FDA import refusal record(s) in our database, spanning from 12/22/2011 to 12/22/2011.
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. Bonarum Pharma Sa De Cv's FEI number is 3009177100.
What types of violations has Bonarum Pharma Sa De Cv received?
Bonarum Pharma Sa De Cv 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 Bonarum Pharma Sa De Cv come from?
All FDA import refusal data for Bonarum Pharma Sa De Cv 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.