Divya Darshan Centre
⚠️ Moderate Risk
FEI: 3004619349 • Bhattha Paldi Ahmedabadd • INDIA
FEI Number
3004619349
Location
Bhattha Paldi Ahmedabadd
Country
INDIAAddress
1 Hiral Complex, , Bhattha Paldi Ahmedabadd, , 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
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 |
|---|---|---|---|
| 8/10/2004 | 61WCL47KETOCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | New York District Office (NYK-DO) | |
| 8/10/2004 | 61QCB05TOLTERODINE TARTRATE (ANTI-DIURETIC) | New York District Office (NYK-DO) | |
| 8/10/2004 | 61XCB45CETIRIZINE HYDROCHLORIDE (ANTI-HISTAMINIC) | New York District Office (NYK-DO) | |
| 8/10/2004 | 65LBJ15ZINC OXIDE PASTE WITH SALICYLIC ACID (PROTECTANT) | New York District Office (NYK-DO) | |
| 8/10/2004 | 62FBJ46CAMPHORATED PARACHLOROPHENOL (ANTI-INFECTIVE, TOPICAL) | New York District Office (NYK-DO) | |
| 8/10/2004 | 61FCB61GATIFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Divya Darshan Centre's FDA import refusal history?
Divya Darshan Centre (FEI: 3004619349) has 6 FDA import refusal record(s) in our database, spanning from 8/10/2004 to 8/10/2004.
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. Divya Darshan Centre's FEI number is 3004619349.
What types of violations has Divya Darshan Centre received?
Divya Darshan Centre 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 Divya Darshan Centre come from?
All FDA import refusal data for Divya Darshan Centre 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.