Phytomed Medicinal Herbs
⚠️ Moderate Risk
FEI: 3006001283 • Auckland • NEW ZEALAND
FEI Number
3006001283
Location
Auckland
Country
NEW ZEALANDAddress
438 Rosebank Road, , Auckland, , New Zealand
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
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
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 |
|---|---|---|---|
| 4/22/2008 | 66VDL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 12/8/2006 | 53ID02MOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 12/8/2006 | 62UBL99ANTI-TUSSIVE/COLD N.E.C. | 335LACKS N/C | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Phytomed Medicinal Herbs's FDA import refusal history?
Phytomed Medicinal Herbs (FEI: 3006001283) has 3 FDA import refusal record(s) in our database, spanning from 12/8/2006 to 4/22/2008.
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. Phytomed Medicinal Herbs's FEI number is 3006001283.
What types of violations has Phytomed Medicinal Herbs received?
Phytomed Medicinal Herbs 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 Phytomed Medicinal Herbs come from?
All FDA import refusal data for Phytomed Medicinal Herbs 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.