Sun Pharmaceutical Industries (prev. Ranbaxy)
⚠️ Moderate Risk
FEI: 3002807978 • Sirmaur, Himachal Pradesh • INDIA
FEI Number
3002807978
Location
Sirmaur, Himachal Pradesh
Country
INDIAAddress
Village Ganguwala, Tehsil-Paonta Sahib, Sirmaur, Himachal Pradesh, 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
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
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 |
|---|---|---|---|
| 10/21/2022 | 64XCY11ISOTRETINOIN (KERATOLYTIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 4/24/2017 | 60SCA25RANITIDINE HYDROCHLORIDE (ANTACID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/11/2009 | 61JCA16ROSUVASTATIN CALCIUM | 75UNAPPROVED | New York District Office (NYK-DO) |
| 9/29/2008 | 61JCS13PRAVASTATIN SODIUM (ANTI-CHOLESTEREMIC) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 9/29/2008 | 61JCS13PRAVASTATIN SODIUM (ANTI-CHOLESTEREMIC) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 9/29/2008 | 61JCS13PRAVASTATIN SODIUM (ANTI-CHOLESTEREMIC) | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
Frequently Asked Questions
What is Sun Pharmaceutical Industries (prev. Ranbaxy)'s FDA import refusal history?
Sun Pharmaceutical Industries (prev. Ranbaxy) (FEI: 3002807978) has 6 FDA import refusal record(s) in our database, spanning from 9/29/2008 to 10/21/2022.
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. Sun Pharmaceutical Industries (prev. Ranbaxy)'s FEI number is 3002807978.
What types of violations has Sun Pharmaceutical Industries (prev. Ranbaxy) received?
Sun Pharmaceutical Industries (prev. Ranbaxy) 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 Sun Pharmaceutical Industries (prev. Ranbaxy) come from?
All FDA import refusal data for Sun Pharmaceutical Industries (prev. Ranbaxy) 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.