Dr, Vidya Ohatker
⚠️ High Risk
FEI: 3004359679 • Bombay • INDIA
FEI Number
3004359679
Location
Bombay
Country
INDIAAddress
Kanakias Beverly Park Mira Road 401 107, , Bombay, , 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
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).
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/28/2004 | 61XBB99ANTI-HISTAMINIC N.E.C. | New York District Office (NYK-DO) | |
| 4/28/2004 | 60WCA99ANTHELMINTIC, N.E.C. | New York District Office (NYK-DO) | |
| 4/28/2004 | 60LAJ01ACETAMINOPHEN (ANALGESIC) | New York District Office (NYK-DO) | |
| 4/28/2004 | 65VCA15DIAZEPAM (SEDATIVE) | New York District Office (NYK-DO) | |
| 4/28/2004 | 66MCA03ALPRAZOLAM (TRANQUILIZER) | New York District Office (NYK-DO) | |
| 4/28/2004 | 62GAA90DICLOFENAC POTASSIUM (ANTI-INFLAMMATORY) | New York District Office (NYK-DO) | |
| 4/28/2004 | 62GAA90DICLOFENAC POTASSIUM (ANTI-INFLAMMATORY) | New York District Office (NYK-DO) | |
| 4/28/2004 | 60LAJ01ACETAMINOPHEN (ANALGESIC) | New York District Office (NYK-DO) | |
| 4/28/2004 | 60LAA01ACETAMINOPHEN (ANALGESIC) | New York District Office (NYK-DO) | |
| 4/28/2004 | 61WAO04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | New York District Office (NYK-DO) | |
| 4/28/2004 | 63AAA99BONE CALCIUM REGULATOR N.E.C. | New York District Office (NYK-DO) | |
| 4/28/2004 | 56ECE20DOXYCYCLINE (TETRACYCLINES) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Dr, Vidya Ohatker's FDA import refusal history?
Dr, Vidya Ohatker (FEI: 3004359679) has 12 FDA import refusal record(s) in our database, spanning from 4/28/2004 to 4/28/2004.
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. Dr, Vidya Ohatker's FEI number is 3004359679.
What types of violations has Dr, Vidya Ohatker received?
Dr, Vidya Ohatker 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 Dr, Vidya Ohatker come from?
All FDA import refusal data for Dr, Vidya Ohatker 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.