RPG Life Sciences Limited
⚠️ High Risk
FEI: 3008314161 • Ankleshwar, Gujarat • INDIA
FEI Number
3008314161
Location
Ankleshwar, Gujarat
Country
INDIAAddress
3102/A G Sf-12 Shrinathji Arcade, Karmatur Road, Ankleshwar, Gujarat, 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
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).
FDF4APIGMP
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods and controls used in its manufacture and control do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B). This finished dosage form drug is made using an Active Pharmaceutical Ingredient from a facility that has been found non-compliant with current Good Manufacturing Practice (see Import Alert 66-40; http://www.accessdata.fda.gov/cms_ia/importalert_189.html). You may submit testimony to provide evidence to overcome the appearance of adulteration. The API source for this finished dosage form drug is:
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/9/2023 | 64TBY01AZATHIOPRINE (IMMUNOSUPPRESSIVE) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 1/12/2023 | 62KDA03DIPHENOXYLATE HCL (ANTI-PERISTALTIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 12/9/2022 | 64BCY37SPIRONOLACTONE (DIURETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/30/2022 | 56EDY22DOXYCYCLINE HYCLATE (TETRACYCLINES) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 10/19/2021 | 64TCA01AZATHIOPRINE (IMMUNOSUPPRESSIVE) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 10/15/2021 | 64BCA37SPIRONOLACTONE (DIURETIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 10/15/2021 | 62KDA03DIPHENOXYLATE HCL (ANTI-PERISTALTIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 11/24/2020 | 62KDY03DIPHENOXYLATE HCL (ANTI-PERISTALTIC) | Division of Southeast Imports (DSEI) | |
| 6/2/2020 | 64BCE37SPIRONOLACTONE (DIURETIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 11/18/2019 | 62GAA49NAPROXEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/26/2019 | 62GCC49NAPROXEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/18/2017 | 64BCA37SPIRONOLACTONE (DIURETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/26/2016 | 64TDY01AZATHIOPRINE (IMMUNOSUPPRESSIVE) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 11/19/2015 | 64BDY37SPIRONOLACTONE (DIURETIC) | 27DRUG GMPS | Cincinnati District Office (CIN-DO) |
| 11/25/2014 | 64TCA01AZATHIOPRINE (IMMUNOSUPPRESSIVE) | 27DRUG GMPS | Cincinnati District Office (CIN-DO) |
| 3/13/2014 | 61KCC05ATROPINE SULFATE (ANTI-CHOLINERGIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is RPG Life Sciences Limited's FDA import refusal history?
RPG Life Sciences Limited (FEI: 3008314161) has 16 FDA import refusal record(s) in our database, spanning from 3/13/2014 to 3/9/2023.
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. RPG Life Sciences Limited's FEI number is 3008314161.
What types of violations has RPG Life Sciences Limited received?
RPG Life Sciences Limited has been cited for 3 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 RPG Life Sciences Limited come from?
All FDA import refusal data for RPG Life Sciences Limited 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.