BIO-GULF SDN BHD
⚠️ Moderate Risk
FEI: 3009262655 • Kuala Lumpur, Wilayah Persekutuan • MALAYSIA
FEI Number
3009262655
Location
Kuala Lumpur, Wilayah Persekutuan
Country
MALAYSIAAddress
Plaza Damansara, 24 2 Jalan, Kuala Lumpur, Wilayah Persekutuan, Malaysia
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
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
FALSE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/18/2009 | 54FCA99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/31/2009 | 54AYY99VITAMIN, N.E.C. | 488HEALTH C | New Orleans District Office (NOL-DO) |
| 7/31/2009 | 54YDA99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 488HEALTH C | New Orleans District Office (NOL-DO) |
| 7/31/2008 | 54FCA48GINKGO BILOBA (HERBAL & BOTANICALS, NOT TEAS) | 260FALSE | New Orleans District Office (NOL-DO) |
| 7/23/2008 | 54FCA48GINKGO BILOBA (HERBAL & BOTANICALS, NOT TEAS) | 488HEALTH C | New Orleans District Office (NOL-DO) |
| 7/21/2008 | 54FEA99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/9/2008 | 54FCA48GINKGO BILOBA (HERBAL & BOTANICALS, NOT TEAS) | 488HEALTH C | New Orleans District Office (NOL-DO) |
| 2/8/2005 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Seattle District Office (SEA-DO) | |
| 1/26/2005 | 66BBE99STIMULANT N.E.C. | 75UNAPPROVED | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is BIO-GULF SDN BHD's FDA import refusal history?
BIO-GULF SDN BHD (FEI: 3009262655) has 9 FDA import refusal record(s) in our database, spanning from 1/26/2005 to 9/18/2009.
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-GULF SDN BHD's FEI number is 3009262655.
What types of violations has BIO-GULF SDN BHD received?
BIO-GULF SDN BHD has been cited for 5 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-GULF SDN BHD come from?
All FDA import refusal data for BIO-GULF SDN BHD 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.