SUN PHARMA LABORATORIES LTD
⚠️ High Risk
FEI: 3016601401 • Assam • 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
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).
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/10/2025 | 61XDY51LEVOCETIRIZINE DIHYDROCHLORIDE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/9/2025 | 61NCC29FLUOXETINE (ANTI-DEPRESSANT) | Division of Southeast Imports (DSEI) | |
| 8/22/2025 | 62TDY07PANTOPRAZOLE SODIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/11/2025 | 61PDY70DAPAGLIFLOZIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/11/2025 | 62TCY06ESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY) | Division of Southeast Imports (DSEI) | |
| 4/21/2025 | 62TDY06ESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 3/21/2025 | 62VCC01AMANTADINE HCL (ANTI-VIRAL) | Division of Southeast Imports (DSEI) | |
| 6/12/2024 | 62CCY99ANTI-HYPERTENSIVE N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/8/2022 | 61TCA37AMISULPRIDE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/8/2022 | 61NCA29FLUOXETINE (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/27/2022 | 66YDY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/25/2022 | 65KCY10BIMATOPROST (PROSTAGLANDIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/21/2021 | 62ODY15BENAZEPRIL HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is SUN PHARMA LABORATORIES LTD's FDA import refusal history?
SUN PHARMA LABORATORIES LTD (FEI: 3016601401) has 13 FDA import refusal record(s) in our database, spanning from 12/21/2021 to 11/10/2025.
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 PHARMA LABORATORIES LTD's FEI number is 3016601401.
What types of violations has SUN PHARMA LABORATORIES LTD received?
SUN PHARMA LABORATORIES LTD 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 SUN PHARMA LABORATORIES LTD come from?
All FDA import refusal data for SUN PHARMA LABORATORIES 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.