Biomed Healthcare Products Pvt. Ltd.
⚠️ Moderate Risk
FEI: 3005696000 • Haryana • INDIA
FEI Number
3005696000
Location
Haryana
Country
INDIAAddress
30, DLF Industrial Estate -1, , Faridabad, Haryana, , 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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/4/2013 | 79GBNCATHETER, PEDIATRIC, GENERAL & PLASTIC SURGERY | 118NOT LISTED | Florida District Office (FLA-DO) |
| 7/24/2012 | 79KCECANNULAE, BRONCHIAL | Division of Southeast Imports (DSEI) | |
| 10/20/2011 | 79KCECANNULAE, BRONCHIAL | Division of Southeast Imports (DSEI) | |
| 2/9/2011 | 79KCECANNULAE, BRONCHIAL | Division of Southeast Imports (DSEI) | |
| 12/1/2010 | 79KCECANNULAE, BRONCHIAL | Division of Southeast Imports (DSEI) | |
| 10/15/2009 | 79KCECANNULAE, BRONCHIAL | 118NOT LISTED | Florida District Office (FLA-DO) |
| 4/2/2008 | 79KCECANNULAE, BRONCHIAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Biomed Healthcare Products Pvt. Ltd.'s FDA import refusal history?
Biomed Healthcare Products Pvt. Ltd. (FEI: 3005696000) has 7 FDA import refusal record(s) in our database, spanning from 4/2/2008 to 3/4/2013.
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. Biomed Healthcare Products Pvt. Ltd.'s FEI number is 3005696000.
What types of violations has Biomed Healthcare Products Pvt. Ltd. received?
Biomed Healthcare Products Pvt. 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 Biomed Healthcare Products Pvt. Ltd. come from?
All FDA import refusal data for Biomed Healthcare Products 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.