Biotivity SDN BHD
⚠️ Moderate Risk
FEI: 3011924945 • Bota, Perak • MALAYSIA
FEI Number
3011924945
Location
Bota, Perak
Country
MALAYSIAAddress
Lot 6384, Jalan Gelung Pepuyu, Bota, Perak, 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
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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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.
DIETARYLBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.
NCONTACT
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
POISONOUS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. Contains:
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/19/2021 | 36CYY99HONEY, N.E.C. | 251POISONOUS | Division of Southeast Imports (DSEI) |
| 3/29/2019 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/20/2019 | 25LYH24GINGER ROOT, DRIED OR PASTE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/4/2019 | 36CGT04HONEY | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/28/2019 | 36CGT04HONEY | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/9/2018 | 36CYY99HONEY, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/10/2017 | 36CGT04HONEY | 473LABELING | Division of Southeast Imports (DSEI) |
| 7/17/2017 | 54YCY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 7/17/2017 | 36CGT04HONEY | Division of Southeast Imports (DSEI) | |
| 6/29/2017 | 54FCY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Biotivity SDN BHD's FDA import refusal history?
Biotivity SDN BHD (FEI: 3011924945) has 10 FDA import refusal record(s) in our database, spanning from 6/29/2017 to 2/19/2021.
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. Biotivity SDN BHD's FEI number is 3011924945.
What types of violations has Biotivity SDN BHD received?
Biotivity SDN BHD has been cited for 9 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 Biotivity SDN BHD come from?
All FDA import refusal data for Biotivity 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.