BIO HEALTH PHARMACEUTICALS
⚠️ Moderate Risk
FEI: 3008892933 • Silverwater, New South Wales • AUSTRALIA
FEI Number
3008892933
Location
Silverwater, New South Wales
Country
AUSTRALIAAddress
12 Giffard St, SILVERWATER, Silverwater, New South Wales, 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
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
HEALTH C
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.
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 |
|---|---|---|---|
| 1/18/2013 | 54YBE99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 1/18/2013 | 54YCH99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 5/24/2012 | 54YCR99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Seattle District Office (SEA-DO) | |
| 12/28/2011 | 54AYB99VITAMIN, N.E.C. | 488HEALTH C | New Orleans District Office (NOL-DO) |
| 12/28/2011 | 54AYB99VITAMIN, N.E.C. | 488HEALTH C | New Orleans District Office (NOL-DO) |
| 12/28/2011 | 54AYB99VITAMIN, N.E.C. | New Orleans District Office (NOL-DO) | |
| 12/28/2011 | 54AYB99VITAMIN, N.E.C. | New Orleans District Office (NOL-DO) | |
| 12/28/2011 | 54AYB99VITAMIN, N.E.C. | 482NUTRIT LBL | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is BIO HEALTH PHARMACEUTICALS's FDA import refusal history?
BIO HEALTH PHARMACEUTICALS (FEI: 3008892933) has 8 FDA import refusal record(s) in our database, spanning from 12/28/2011 to 1/18/2013.
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. BIO HEALTH PHARMACEUTICALS's FEI number is 3008892933.
What types of violations has BIO HEALTH PHARMACEUTICALS received?
BIO HEALTH PHARMACEUTICALS 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 BIO HEALTH PHARMACEUTICALS come from?
All FDA import refusal data for BIO HEALTH PHARMACEUTICALS 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.