Pharmacia Brasil Ltdaav Dr Chucri Zaidan
⚠️ Moderate Risk
FEI: 3003374326 • Sao Paulo • BRAZIL
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/10/2011 | 66VIO99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 7/14/2006 | 62CAB99ANTI-HYPERTENSIVE N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/25/2005 | 60RCF07DIETHYLPROPION HCL (ANOREXIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/13/2004 | 61QIY05TOLTERODINE TARTRATE (ANTI-DIURETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/26/2004 | 60CCP46NAPHAZOLINE HCL (ADRENERGIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Pharmacia Brasil Ltdaav Dr Chucri Zaidan's FDA import refusal history?
Pharmacia Brasil Ltdaav Dr Chucri Zaidan (FEI: 3003374326) has 5 FDA import refusal record(s) in our database, spanning from 8/26/2004 to 11/10/2011.
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. Pharmacia Brasil Ltdaav Dr Chucri Zaidan's FEI number is 3003374326.
What types of violations has Pharmacia Brasil Ltdaav Dr Chucri Zaidan received?
Pharmacia Brasil Ltdaav Dr Chucri Zaidan 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 Pharmacia Brasil Ltdaav Dr Chucri Zaidan come from?
All FDA import refusal data for Pharmacia Brasil Ltdaav Dr Chucri Zaidan 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.