Telesky Shopping P
⚠️ High Risk
FEI: 3009384089 • Mumbai, Maharashtra • INDIA
FEI Number
3009384089
Location
Mumbai, Maharashtra
Country
INDIAAddress
22 Morya House, , Mumbai, Maharashtra, 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 |
|---|---|---|---|
| 10/17/2012 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | New Orleans District Office (NOL-DO) | |
| 7/25/2012 | 66VBE99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 7/20/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/20/2012 | 60RDY99ANOREXIC, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/13/2012 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/13/2012 | 54FCE99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/13/2012 | 66VIE99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/6/2012 | 66VDB99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 7/6/2012 | 54ACE99VITAMIN, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/6/2012 | 54YBE99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/3/2012 | 61PIE99ANTI-DIABETIC N.E.C. | New Orleans District Office (NOL-DO) | |
| 6/20/2012 | 66VDB99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 6/18/2012 | 54FBE99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/8/2012 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 6/8/2012 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Telesky Shopping P's FDA import refusal history?
Telesky Shopping P (FEI: 3009384089) has 15 FDA import refusal record(s) in our database, spanning from 6/8/2012 to 10/17/2012.
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. Telesky Shopping P's FEI number is 3009384089.
What types of violations has Telesky Shopping P received?
Telesky Shopping P 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 Telesky Shopping P come from?
All FDA import refusal data for Telesky Shopping P 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.