Kronox Lab Sciences Private Ltd.
⚠️ High Risk
FEI: 3009231538 • Vadodara, Gujarat • INDIA
FEI Number
3009231538
Location
Vadodara, Gujarat
Country
INDIAAddress
284 AT Dabhasa TAL Padra, , Vadodara, 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
DRG REF EI
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article of drug appears to be adulterated under Section 501(j) because it has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/5/2024 | 55RP99PHARMACEUTIC NECESSITIES, N.E.C. | 3845DRG REF EI | Division of Northeast Imports (DNEI) |
| 4/5/2024 | 55RP99PHARMACEUTIC NECESSITIES, N.E.C. | 3845DRG REF EI | Division of Northeast Imports (DNEI) |
| 4/5/2024 | 55RP99PHARMACEUTIC NECESSITIES, N.E.C. | 3845DRG REF EI | Division of Northeast Imports (DNEI) |
| 4/5/2024 | 55RP99PHARMACEUTIC NECESSITIES, N.E.C. | 3845DRG REF EI | Division of Northeast Imports (DNEI) |
| 4/5/2024 | 55RP99PHARMACEUTIC NECESSITIES, N.E.C. | 3845DRG REF EI | Division of Northeast Imports (DNEI) |
| 4/5/2024 | 55RP99PHARMACEUTIC NECESSITIES, N.E.C. | 3845DRG REF EI | Division of Northeast Imports (DNEI) |
| 3/19/2024 | 55RP99PHARMACEUTIC NECESSITIES, N.E.C. | 3845DRG REF EI | Division of Southeast Imports (DSEI) |
| 4/2/2021 | 55RP99PHARMACEUTIC NECESSITIES, N.E.C. | 3845DRG REF EI | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Kronox Lab Sciences Private Ltd.'s FDA import refusal history?
Kronox Lab Sciences Private Ltd. (FEI: 3009231538) has 8 FDA import refusal record(s) in our database, spanning from 4/2/2021 to 4/5/2024.
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. Kronox Lab Sciences Private Ltd.'s FEI number is 3009231538.
What types of violations has Kronox Lab Sciences Private Ltd. received?
Kronox Lab Sciences Private Ltd. 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 Kronox Lab Sciences Private Ltd. come from?
All FDA import refusal data for Kronox Lab Sciences Private 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.