Bioprist Pharmaceutical
⚠️ Moderate Risk
FEI: 3009690740 • Houston, TX • UNITED STATES
FEI Number
3009690740
Location
Houston, TX
Country
UNITED STATESAddress
5600 Binhill Dr, , Houston, TX, United States
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 |
|---|---|---|---|
| 5/25/2016 | 64BDA48INDAPAMIDE (DIURETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/25/2016 | 62CDA65LISINOPRIL (ANTI-HYPERTENSIVE) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/11/2016 | 62LCA09TINIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 4/1/2016 | 61JIA08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 8/15/2012 | 61LCA38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 8/15/2012 | 54AFA99VITAMIN, N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Bioprist Pharmaceutical's FDA import refusal history?
Bioprist Pharmaceutical (FEI: 3009690740) has 6 FDA import refusal record(s) in our database, spanning from 8/15/2012 to 5/25/2016.
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. Bioprist Pharmaceutical's FEI number is 3009690740.
What types of violations has Bioprist Pharmaceutical received?
Bioprist Pharmaceutical 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 Bioprist Pharmaceutical come from?
All FDA import refusal data for Bioprist Pharmaceutical 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.