BioCina Adelaide
⚠️ Moderate Risk
FEI: 3003961774 • Thebarton, South Australia • AUSTRALIA
FEI Number
3003961774
Location
Thebarton, South Australia
Country
AUSTRALIAAddress
8 Dalgleish St, , Thebarton, South Australia, Australia
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).
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/24/2006 | 64RDS22SOMATROPIN (RDNA ORIGIN) (HORMONE) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 2/9/2005 | 64ROL21SOMATROPIN (HORMONE) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 10/9/2004 | 64ROL21SOMATROPIN (HORMONE) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 5/18/2004 | 64ROL21SOMATROPIN (HORMONE) | 72NEW VET DR | New York District Office (NYK-DO) |
Frequently Asked Questions
What is BioCina Adelaide's FDA import refusal history?
BioCina Adelaide (FEI: 3003961774) has 4 FDA import refusal record(s) in our database, spanning from 5/18/2004 to 10/24/2006.
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. BioCina Adelaide's FEI number is 3003961774.
What types of violations has BioCina Adelaide received?
BioCina Adelaide 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 BioCina Adelaide come from?
All FDA import refusal data for BioCina Adelaide 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.