AAVUGARI SURYA KIRAN
⚠️ High Risk
FEI: 3026480311 • Hyderabad • INDIA
FEI Number
3026480311
Location
Hyderabad
Country
INDIAAddress
45 237 E Ananbagh Moula, , Hyderabad, , 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
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 |
|---|---|---|---|
| 9/25/2025 | 61PCY99ANTI-DIABETIC N.E.C. | Division of Southeast Imports (DSEI) | |
| 9/25/2025 | 62ODY14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | Division of Southeast Imports (DSEI) | |
| 9/25/2025 | 60SDY07PRECIPITATED CALCIUM CARBONATE (ANTACID) | Division of Southeast Imports (DSEI) | |
| 9/25/2025 | 60LDY01ACETAMINOPHEN (ANALGESIC) | Division of Southeast Imports (DSEI) | |
| 9/25/2025 | 66JCY01LEVOTHYROXINE SODIUM (THYROID HORMONE) | Division of Southeast Imports (DSEI) | |
| 9/25/2025 | 62OCY09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | Division of Southeast Imports (DSEI) | |
| 9/25/2025 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 9/25/2025 | 60LDY01ACETAMINOPHEN (ANALGESIC) | Division of Southeast Imports (DSEI) | |
| 9/25/2025 | 66JCY01LEVOTHYROXINE SODIUM (THYROID HORMONE) | Division of Southeast Imports (DSEI) | |
| 9/25/2025 | 61PCY99ANTI-DIABETIC N.E.C. | Division of Southeast Imports (DSEI) | |
| 9/25/2025 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 9/25/2025 | 61PCY70DAPAGLIFLOZIN (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) | |
| 9/25/2025 | 61PCY99ANTI-DIABETIC N.E.C. | Division of Southeast Imports (DSEI) | |
| 9/25/2025 | 62TCY07PANTOPRAZOLE SODIUM | Division of Southeast Imports (DSEI) | |
| 9/25/2025 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 9/25/2025 | 61JDY08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | Division of Southeast Imports (DSEI) | |
| 9/25/2025 | 61PCY99ANTI-DIABETIC N.E.C. | Division of Southeast Imports (DSEI) | |
| 9/25/2025 | 64BDY25HYDROCHLOROTHIAZIDE (DIURETIC) | Division of Southeast Imports (DSEI) | |
| 9/25/2025 | 61EDY09MONTELUKAST SODIUM (ANTI-ASTHMATIC) | Division of Southeast Imports (DSEI) | |
| 9/25/2025 | 61JDY16ROSUVASTATIN CALCIUM | Division of Southeast Imports (DSEI) | |
| 9/25/2025 | 61TDY31DOMPERIDONE | Division of Southeast Imports (DSEI) | |
| 9/25/2025 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 9/25/2025 | 56BCY03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | Division of Southeast Imports (DSEI) | |
| 9/25/2025 | 61XDY08CHLORPHENIRAMINE MALEATE (ANTI-HISTAMINIC) | Division of Southeast Imports (DSEI) | |
| 9/25/2025 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is AAVUGARI SURYA KIRAN's FDA import refusal history?
AAVUGARI SURYA KIRAN (FEI: 3026480311) has 25 FDA import refusal record(s) in our database, spanning from 9/25/2025 to 9/25/2025.
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. AAVUGARI SURYA KIRAN's FEI number is 3026480311.
What types of violations has AAVUGARI SURYA KIRAN received?
AAVUGARI SURYA KIRAN 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 AAVUGARI SURYA KIRAN come from?
All FDA import refusal data for AAVUGARI SURYA KIRAN 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.