Serpaprosa/Aeroflash
⚠️ High Risk
FEI: 3006131516 • Mexicomexico • MEXICO
FEI Number
3006131516
Location
Mexicomexico
Country
MEXICOAddress
Sala A Local A 25aeropuerto Intl Benito, , Mexicomexico, , Mexico
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/12/2008 | 60WCA16MEBENDAZOLE (ANTHELMINTIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 11/12/2008 | 63BCY13METAPROTERENOL SULFATE (BRONCHODILATOR) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 5/24/2007 | 66VCK99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 5/23/2007 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 5/23/2007 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/26/2007 | 61MCA23PHENYTOIN (ANTI-CONVULSANT) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/26/2007 | 61MCA24PHENYTOIN SODIUM (ANTI-CONVULSANT) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/11/2007 | 62GCA18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/11/2007 | 64BCA09BUMETANIDE (DIURETIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/11/2007 | 61FCA54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Serpaprosa/Aeroflash's FDA import refusal history?
Serpaprosa/Aeroflash (FEI: 3006131516) has 10 FDA import refusal record(s) in our database, spanning from 4/11/2007 to 11/12/2008.
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. Serpaprosa/Aeroflash's FEI number is 3006131516.
What types of violations has Serpaprosa/Aeroflash received?
Serpaprosa/Aeroflash 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 Serpaprosa/Aeroflash come from?
All FDA import refusal data for Serpaprosa/Aeroflash 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.