Shoney Scientific India
⚠️ Moderate Risk
FEI: 3002731916 • Pondicherry • INDIA
FEI Number
3002731916
Location
Pondicherry
Country
INDIAAddress
A30/B, Thattanchavady, Industrial Estate, Pondicherry, , 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
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/15/2014 | 79MJGDEVICE, PERCUTANEOUS, BIOPSY | Chicago District Office (CHI-DO) | |
| 4/4/2014 | 79MJGDEVICE, PERCUTANEOUS, BIOPSY | 2780DEVICEGMPS | Minneapolis District Office (MIN-DO) |
| 4/4/2014 | 85HHMSOUND, UTERINE | 2780DEVICEGMPS | Minneapolis District Office (MIN-DO) |
| 4/4/2014 | 85HCYCURETTE, UTERINE | 2780DEVICEGMPS | Minneapolis District Office (MIN-DO) |
| 3/28/2014 | 79MJGDEVICE, PERCUTANEOUS, BIOPSY | 2780DEVICEGMPS | Minneapolis District Office (MIN-DO) |
| 3/6/2014 | 79MJGDEVICE, PERCUTANEOUS, BIOPSY | 2780DEVICEGMPS | Minneapolis District Office (MIN-DO) |
| 3/6/2014 | 79FZSCURETTE, SURGICAL | 2780DEVICEGMPS | Minneapolis District Office (MIN-DO) |
| 3/6/2014 | 79MJGDEVICE, PERCUTANEOUS, BIOPSY | 2780DEVICEGMPS | Minneapolis District Office (MIN-DO) |
| 3/6/2014 | 79MJGDEVICE, PERCUTANEOUS, BIOPSY | 2780DEVICEGMPS | Minneapolis District Office (MIN-DO) |
| 2/6/2014 | 79MJGDEVICE, PERCUTANEOUS, BIOPSY | 2780DEVICEGMPS | Minneapolis District Office (MIN-DO) |
| 2/5/2014 | 76EMEPUNCH, BIOPSY, SURGICAL | 2780DEVICEGMPS | New Orleans District Office (NOL-DO) |
| 2/5/2014 | 79GEACANNULA, SURGICAL, GENERAL & PLASTIC SURGERY | 2780DEVICEGMPS | New Orleans District Office (NOL-DO) |
| 8/31/2004 | 79LRYPUNCH, SURGICAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/31/2004 | 79GFABLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Shoney Scientific India's FDA import refusal history?
Shoney Scientific India (FEI: 3002731916) has 14 FDA import refusal record(s) in our database, spanning from 8/31/2004 to 7/15/2014.
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. Shoney Scientific India's FEI number is 3002731916.
What types of violations has Shoney Scientific India received?
Shoney Scientific India has been cited for 3 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 Shoney Scientific India come from?
All FDA import refusal data for Shoney Scientific India 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.