Shree Marwal Sevashram
⚠️ High Risk
FEI: 3008855266 • Indore, Madhya Pradesh • INDIA
FEI Number
3008855266
Location
Indore, Madhya Pradesh
Country
INDIAAddress
4 - 5 A B Industrial Est, Plot No; Baolia Khurd, Indore, Madhya Pradesh, India
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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).
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/9/2013 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 9/14/2012 | 66VBK99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 9/7/2012 | 60LCL99ANALGESIC, N.E.C. | New Orleans District Office (NOL-DO) | |
| 8/15/2012 | 66VCL99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 8/14/2012 | 66VBO99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/14/2012 | 60LAL99ANALGESIC, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/9/2012 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 8/9/2012 | 62GBX99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/7/2012 | 62GBK99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/2/2012 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/27/2012 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/6/2012 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/6/2012 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/20/2012 | 60LBL99ANALGESIC, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/27/2011 | 62GBY99ANTI-INFLAMMATORY N.E.C. | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Shree Marwal Sevashram's FDA import refusal history?
Shree Marwal Sevashram (FEI: 3008855266) has 15 FDA import refusal record(s) in our database, spanning from 6/27/2011 to 10/9/2013.
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. Shree Marwal Sevashram's FEI number is 3008855266.
What types of violations has Shree Marwal Sevashram received?
Shree Marwal Sevashram 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 Marwal Sevashram come from?
All FDA import refusal data for Shree Marwal Sevashram 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.