Hettigoda Industries(Pvt)Ltd
⚠️ Moderate Risk
FEI: 3001242717 • Ratmalana • SRI LANKA
FEI Number
3001242717
Location
Ratmalana
Country
SRI LANKAAddress
33/3 Dharmarama Road, , Ratmalana, , Sri Lanka
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
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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).
DR QUALITC
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the drug appears to be represented as not being recognized in an official compendium and appears its strength differs from or its quality or purity falls below, that which it purports or is represented to possess.
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 |
|---|---|---|---|
| 6/14/2017 | 54FYY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 4/17/2008 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 4/17/2008 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 7/7/2006 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 4/13/2004 | 61XAQ99ANTI-HISTAMINIC N.E.C. | 331DR QUALITC | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Hettigoda Industries(Pvt)Ltd's FDA import refusal history?
Hettigoda Industries(Pvt)Ltd (FEI: 3001242717) has 5 FDA import refusal record(s) in our database, spanning from 4/13/2004 to 6/14/2017.
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. Hettigoda Industries(Pvt)Ltd's FEI number is 3001242717.
What types of violations has Hettigoda Industries(Pvt)Ltd received?
Hettigoda Industries(Pvt)Ltd 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 Hettigoda Industries(Pvt)Ltd come from?
All FDA import refusal data for Hettigoda Industries(Pvt)Ltd 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.