Green Chemlakshmi 5
⚠️ Moderate Risk
FEI: 3005078167 • Bangalore • INDIA
FEI Number
3005078167
Location
Bangalore
Country
INDIAAddress
Domlur 2nd Stage, 3rd Phase, , Bangalore, , India
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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
FILTHY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/8/2010 | 50LYY35KUDZU ROOT | 249FILTHY | Los Angeles District Office (LOS-DO) |
| 2/18/2009 | 54FBR99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Los Angeles District Office (LOS-DO) | |
| 4/26/2007 | 66VAR99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Green Chemlakshmi 5's FDA import refusal history?
Green Chemlakshmi 5 (FEI: 3005078167) has 3 FDA import refusal record(s) in our database, spanning from 4/26/2007 to 12/8/2010.
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. Green Chemlakshmi 5's FEI number is 3005078167.
What types of violations has Green Chemlakshmi 5 received?
Green Chemlakshmi 5 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 Green Chemlakshmi 5 come from?
All FDA import refusal data for Green Chemlakshmi 5 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.