Stanislaw R Burzynski, MD
⚠️ Moderate Risk
FEI: 3003426453 • Houston, TX • UNITED STATES
FEI Number
3003426453
Location
Houston, TX
Country
UNITED STATESAddress
9432 Katy Fwy, , 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
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).
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
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 |
|---|---|---|---|
| 12/3/2010 | 80NZWHEPARIN VASCULAR ACCESS FLUSH | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/3/2010 | 80FRNPUMP, INFUSION | 341REGISTERED | Florida District Office (FLA-DO) |
| 12/3/2010 | 73BTYCALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION | 341REGISTERED | Florida District Office (FLA-DO) |
| 12/3/2010 | 73BTRTUBE, TRACHEAL (W/WO CONNECTOR) | 341REGISTERED | Florida District Office (FLA-DO) |
| 12/3/2010 | 80KZHINTRODUCER, SYRINGE NEEDLE | 341REGISTERED | Florida District Office (FLA-DO) |
| 12/3/2010 | 79LRSI.V. START KIT | 341REGISTERED | Florida District Office (FLA-DO) |
| 12/3/2010 | 65RCK12POTASSIC SALINE (INJECTION) (REPLENISHER) | 179AGR RX | Florida District Office (FLA-DO) |
| 12/3/2010 | 62IDK99ANTI-NEOPLASTIC N.E.C. | 179AGR RX | Florida District Office (FLA-DO) |
| 12/3/2010 | 62IDK99ANTI-NEOPLASTIC N.E.C. | 179AGR RX | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Stanislaw R Burzynski, MD's FDA import refusal history?
Stanislaw R Burzynski, MD (FEI: 3003426453) has 9 FDA import refusal record(s) in our database, spanning from 12/3/2010 to 12/3/2010.
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. Stanislaw R Burzynski, MD's FEI number is 3003426453.
What types of violations has Stanislaw R Burzynski, MD received?
Stanislaw R Burzynski, MD 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 Stanislaw R Burzynski, MD come from?
All FDA import refusal data for Stanislaw R Burzynski, MD 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.