Pn Viswanavathan
⚠️ Moderate Risk
FEI: 3006334542 • Chennai • INDIA
FEI Number
3006334542
Location
Chennai
Country
INDIAAddress
B-18 Second Fl 23/40 Sarojoni St, , Chennai, , 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
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 |
|---|---|---|---|
| 8/1/2007 | 61JCA08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 118NOT LISTED | New York District Office (NYK-DO) |
| 8/1/2007 | 61XCA45CETIRIZINE HYDROCHLORIDE (ANTI-HISTAMINIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 8/1/2007 | 62FCQ53MOMETASONE FUROATE (ANTI-INFECTIVE, TOPICAL) | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Pn Viswanavathan's FDA import refusal history?
Pn Viswanavathan (FEI: 3006334542) has 3 FDA import refusal record(s) in our database, spanning from 8/1/2007 to 8/1/2007.
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. Pn Viswanavathan's FEI number is 3006334542.
What types of violations has Pn Viswanavathan received?
Pn Viswanavathan 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 Pn Viswanavathan come from?
All FDA import refusal data for Pn Viswanavathan 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.