Danopharm Chemicals Pvt. Ltd.
⚠️ Moderate Risk
FEI: 3012260086 • Ankleshwar, Gujarat • INDIA
FEI Number
3012260086
Location
Ankleshwar, Gujarat
Country
INDIAAddress
C-1/7131,7132,7133, Gidc Estate, Dist. Bharuch, Ankleshwar, Gujarat, 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
REFUSE EI
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.
DRG REF EI
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article of drug appears to be adulterated under Section 501(j) because it has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.
Refusal History
Frequently Asked Questions
What is Danopharm Chemicals Pvt. Ltd.'s FDA import refusal history?
Danopharm Chemicals Pvt. Ltd. (FEI: 3012260086) has 1 FDA import refusal record(s) in our database, spanning from 1/27/2021 to 1/27/2021.
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. Danopharm Chemicals Pvt. Ltd.'s FEI number is 3012260086.
What types of violations has Danopharm Chemicals Pvt. Ltd. received?
Danopharm Chemicals Pvt. Ltd. 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 Danopharm Chemicals Pvt. Ltd. come from?
All FDA import refusal data for Danopharm Chemicals Pvt. Ltd. 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.