Shreeji Masala Products Pvt Ltd
⚠️ Moderate Risk
FEI: 3013265806 • Navi Mumbai, Maharashtra • INDIA
FEI Number
3013265806
Location
Navi Mumbai, Maharashtra
Country
INDIAAddress
Midc, T T C Indl Area; Village Khairane, Navi Mumbai, Maharashtra, 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).
FALSE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
COLOR LBLG
The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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
Frequently Asked Questions
What is Shreeji Masala Products Pvt Ltd's FDA import refusal history?
Shreeji Masala Products Pvt Ltd (FEI: 3013265806) has 3 FDA import refusal record(s) in our database, spanning from 10/7/2009 to 12/7/2011.
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. Shreeji Masala Products Pvt Ltd's FEI number is 3013265806.
What types of violations has Shreeji Masala Products Pvt Ltd received?
Shreeji Masala Products Pvt Ltd 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 Shreeji Masala Products Pvt Ltd come from?
All FDA import refusal data for Shreeji Masala 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.