CELEST PHARMA LABS PVT L.T.D
⚠️ Moderate Risk
FEI: 3016670193 • Bangalore • INDIA
FEI Number
3016670193
Location
Bangalore
Country
INDIAAddress
68 6th Main 3rd Phase P, , Bangalore, , 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
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 |
|---|---|---|---|
| 2/24/2023 | 63XCY39THROMBOPLASTIN (DIAGNOSTIC AID) (DRUGS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is CELEST PHARMA LABS PVT L.T.D's FDA import refusal history?
CELEST PHARMA LABS PVT L.T.D (FEI: 3016670193) has 1 FDA import refusal record(s) in our database, spanning from 2/24/2023 to 2/24/2023.
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. CELEST PHARMA LABS PVT L.T.D's FEI number is 3016670193.
What types of violations has CELEST PHARMA LABS PVT L.T.D received?
CELEST PHARMA LABS PVT L.T.D has been cited for 1 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 CELEST PHARMA LABS PVT L.T.D come from?
All FDA import refusal data for CELEST PHARMA LABS PVT L.T.D 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.