Angiplast Private Limited
⚠️ Moderate Risk
FEI: 3003348363 • Daskroi, Gujarat • INDIA
FEI Number
3003348363
Location
Daskroi, Gujarat
Country
INDIAAddress
4803 Phase Iv, , Daskroi, Gujarat, 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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
STERILITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/3/2019 | 80LHISET, I.V. FLUID TRANSER | Division of Southeast Imports (DSEI) | |
| 7/3/2019 | 80LHISET, I.V. FLUID TRANSER | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 7/11/2003 | 80FMGSTOPCOCK, I.V. SET | Florida District Office (FLA-DO) | |
| 7/11/2003 | 80FMGSTOPCOCK, I.V. SET | Florida District Office (FLA-DO) | |
| 8/2/2002 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Angiplast Private Limited's FDA import refusal history?
Angiplast Private Limited (FEI: 3003348363) has 5 FDA import refusal record(s) in our database, spanning from 8/2/2002 to 7/3/2019.
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. Angiplast Private Limited's FEI number is 3003348363.
What types of violations has Angiplast Private Limited received?
Angiplast Private Limited 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 Angiplast Private Limited come from?
All FDA import refusal data for Angiplast Private Limited 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.