SHREE BALAJI AROMATICS PVT. LTD.
⚠️ Moderate Risk
FEI: 3004273567 • Chandausi, Uttar Pradesh • INDIA
FEI Number
3004273567
Location
Chandausi, Uttar Pradesh
Country
INDIAAddress
Moradabad, , Chandausi, Uttar Pradesh, 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
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.
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).
Refusal History
Frequently Asked Questions
What is SHREE BALAJI AROMATICS PVT. LTD.'s FDA import refusal history?
SHREE BALAJI AROMATICS PVT. LTD. (FEI: 3004273567) has 2 FDA import refusal record(s) in our database, spanning from 12/12/2011 to 12/12/2011.
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. SHREE BALAJI AROMATICS PVT. LTD.'s FEI number is 3004273567.
What types of violations has SHREE BALAJI AROMATICS PVT. LTD. received?
SHREE BALAJI AROMATICS 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 SHREE BALAJI AROMATICS PVT. LTD. come from?
All FDA import refusal data for SHREE BALAJI AROMATICS 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.