Elder Health Care Ltd.
⚠️ Moderate Risk
FEI: 3005151055 • District Raigad, Maharashtra • INDIA
FEI Number
3005151055
Location
District Raigad, Maharashtra
Country
INDIAAddress
Plot No. A-38/3 Area, Village Khaire, Taluka-Khalapur;Patalganga Industrial, District Raigad, Maharashtra, 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
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).
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/29/2007 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 4/4/2006 | 60LOJ99ANALGESIC, N.E.C. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/8/2006 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 2/1/2006 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Elder Health Care Ltd.'s FDA import refusal history?
Elder Health Care Ltd. (FEI: 3005151055) has 4 FDA import refusal record(s) in our database, spanning from 2/1/2006 to 9/29/2007.
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. Elder Health Care Ltd.'s FEI number is 3005151055.
What types of violations has Elder Health Care Ltd. received?
Elder Health Care Ltd. 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 Elder Health Care Ltd. come from?
All FDA import refusal data for Elder Health Care 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.