Amtec Healthcare Pvt Ltd
⚠️ Moderate Risk
FEI: 3009183838 • Maharashta • INDIA
FEI Number
3009183838
Location
Maharashta
Country
INDIAAddress
5/502 Garden Estate Pokhran Rd 2, , Maharashta, , 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).
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 |
|---|---|---|---|
| 7/20/2012 | 65PIY02SILDENAFIL CITRATE (REGULATOR) | Cincinnati District Office (CIN-DO) | |
| 6/5/2012 | 65PIY02SILDENAFIL CITRATE (REGULATOR) | Cincinnati District Office (CIN-DO) | |
| 2/21/2012 | 65PCY02SILDENAFIL CITRATE (REGULATOR) | Cincinnati District Office (CIN-DO) | |
| 11/21/2011 | 65PIY02SILDENAFIL CITRATE (REGULATOR) | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Amtec Healthcare Pvt Ltd's FDA import refusal history?
Amtec Healthcare Pvt Ltd (FEI: 3009183838) has 4 FDA import refusal record(s) in our database, spanning from 11/21/2011 to 7/20/2012.
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. Amtec Healthcare Pvt Ltd's FEI number is 3009183838.
What types of violations has Amtec Healthcare Pvt Ltd received?
Amtec Healthcare Pvt Ltd has been cited for 2 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 Amtec Healthcare Pvt Ltd come from?
All FDA import refusal data for Amtec Healthcare 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.