Akita Herbal Products
⚠️ Moderate Risk
FEI: 3004259397 • Pampanga, Central Luzon • PHILIPPINES
FEI Number
3004259397
Location
Pampanga, Central Luzon
Country
PHILIPPINESAddress
Volga St., Corner Zambensi, Friendship, Pampanga, Central Luzon, Philippines
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).
LACKS FIRM
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(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.
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 |
|---|---|---|---|
| 3/19/2004 | 41YYY99DIETARY CONVENTIONAL FOODS, N.E.C. | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 3/3/2004 | 41YYY99DIETARY CONVENTIONAL FOODS, N.E.C. | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 9/5/2003 | 54YCE99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Akita Herbal Products's FDA import refusal history?
Akita Herbal Products (FEI: 3004259397) has 3 FDA import refusal record(s) in our database, spanning from 9/5/2003 to 3/19/2004.
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. Akita Herbal Products's FEI number is 3004259397.
What types of violations has Akita Herbal Products received?
Akita Herbal Products 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 Akita Herbal Products come from?
All FDA import refusal data for Akita Herbal Products 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.