ANGSTROM BIOTECH
⚠️ Moderate Risk
FEI: 3021492061 • Bhiwadi Rajasthan • INDIA
FEI Number
3021492061
Location
Bhiwadi Rajasthan
Country
INDIAAddress
Plot No G1 1035 Riico I, , Bhiwadi Rajasthan, , 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).
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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
Frequently Asked Questions
What is ANGSTROM BIOTECH's FDA import refusal history?
ANGSTROM BIOTECH (FEI: 3021492061) has 1 FDA import refusal record(s) in our database, spanning from 2/10/2022 to 2/10/2022.
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. ANGSTROM BIOTECH's FEI number is 3021492061.
What types of violations has ANGSTROM BIOTECH received?
ANGSTROM BIOTECH 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 ANGSTROM BIOTECH come from?
All FDA import refusal data for ANGSTROM BIOTECH 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.