Herbal Medical Works Sdn Bhd
⚠️ Moderate Risk
FEI: 3003843218 • Perai, Pulau Pinang • MALAYSIA
FEI Number
3003843218
Location
Perai, Pulau Pinang
Country
MALAYSIAAddress
Lot 2497, Mk1, Lorong Perusahaan Baru 5, Perai, Pulau Pinang, 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
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
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 |
|---|---|---|---|
| 4/11/2006 | 53YC99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 3/8/2006 | 54FYY49GUARANA (HERBAL & BOTANICALS, NOT TEAS) | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 3/8/2006 | 29CYT99NONALCOHOLIC BEVERAGES, N.E.C. | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Herbal Medical Works Sdn Bhd's FDA import refusal history?
Herbal Medical Works Sdn Bhd (FEI: 3003843218) has 3 FDA import refusal record(s) in our database, spanning from 3/8/2006 to 4/11/2006.
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. Herbal Medical Works Sdn Bhd's FEI number is 3003843218.
What types of violations has Herbal Medical Works Sdn Bhd received?
Herbal Medical Works Sdn Bhd has been cited for 2 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 Herbal Medical Works Sdn Bhd come from?
All FDA import refusal data for Herbal Medical Works 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.