Shree Raj Corp
⚠️ Moderate Risk
FEI: 3006348974 • Gandhingai • INDIA
FEI Number
3006348974
Location
Gandhingai
Country
INDIAAddress
Sector 7 B Sector 735, , Gandhingai, , 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).
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/27/2007 | 61XCA45CETIRIZINE HYDROCHLORIDE (ANTI-HISTAMINIC) | 118NOT LISTED | New York District Office (NYK-DO) |
| 8/27/2007 | 63BCA01ALBUTEROL (BRONCHODILATOR) | 118NOT LISTED | New York District Office (NYK-DO) |
| 8/27/2007 | 57GB01ALLERGENIC EXTRACTS, NON-STANDARDIZED | 118NOT LISTED | New York District Office (NYK-DO) |
| 8/27/2007 | 60LAA01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Shree Raj Corp's FDA import refusal history?
Shree Raj Corp (FEI: 3006348974) has 4 FDA import refusal record(s) in our database, spanning from 8/27/2007 to 8/27/2007.
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 Raj Corp's FEI number is 3006348974.
What types of violations has Shree Raj Corp received?
Shree Raj Corp 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 Raj Corp come from?
All FDA import refusal data for Shree Raj Corp 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.