Uniao Quimica Farmaceutica Nacional SA
⚠️ High Risk
FEI: 3004063802 • Guarulhos, Sao Paulo • BRAZIL
FEI Number
3004063802
Location
Guarulhos, Sao Paulo
Country
BRAZILAddress
Avenida Presidente Tancredo De Almeida Neves 1555, , Guarulhos, Sao Paulo, Brazil
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).
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).
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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 |
|---|---|---|---|
| 11/20/2024 | 56BCL03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/3/2024 | 62GDL18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/21/2016 | 61NCA29FLUOXETINE (ANTI-DEPRESSANT) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 9/23/2015 | 61NCA80VENLAFAXINE HYDROCHLORIDE (ANTI-DEPRESSANT) | Florida District Office (FLA-DO) | |
| 9/23/2015 | 66MCA03ALPRAZOLAM (TRANQUILIZER) | Florida District Office (FLA-DO) | |
| 5/31/2012 | 66NAA05ZIPRASIDONE HCI (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II)) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 8/6/2010 | 64XIO07TRETINOIN (KERATOLYTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/29/2007 | 66VCM99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/6/2006 | 55RP13GELATIN (PHARMACEUTIC NECESSITY - SUSPENDING AGENT) | 27DRUG GMPS | Atlanta District Office (ATL-DO) |
| 7/25/2006 | 74NFCSYSTEM, CARDIOVASCULAR, CRYOTHERAPY | New Orleans District Office (NOL-DO) | |
| 7/25/2006 | 74DTQCONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS | New Orleans District Office (NOL-DO) | |
| 7/25/2006 | 74MOUINTRAVASCULAR RADIATION DELIVERY SYSTEM | New Orleans District Office (NOL-DO) | |
| 7/25/2006 | 74NFCSYSTEM, CARDIOVASCULAR, CRYOTHERAPY | New Orleans District Office (NOL-DO) | |
| 7/25/2006 | 74MOUINTRAVASCULAR RADIATION DELIVERY SYSTEM | New Orleans District Office (NOL-DO) | |
| 9/22/2004 | 61NDB99ANTI-DEPRESSANT N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/12/2004 | 60LCY82PHENAZOPYRIDINE HCL (ANALGESIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/12/2004 | 61HCY32NITROFURANTOIN (ANTI-BACTERIAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Uniao Quimica Farmaceutica Nacional SA's FDA import refusal history?
Uniao Quimica Farmaceutica Nacional SA (FEI: 3004063802) has 17 FDA import refusal record(s) in our database, spanning from 4/12/2004 to 11/20/2024.
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. Uniao Quimica Farmaceutica Nacional SA's FEI number is 3004063802.
What types of violations has Uniao Quimica Farmaceutica Nacional SA received?
Uniao Quimica Farmaceutica Nacional SA has been cited for 5 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 Uniao Quimica Farmaceutica Nacional SA come from?
All FDA import refusal data for Uniao Quimica Farmaceutica Nacional SA 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.