Kilitch Healthcare India Limited
⚠️ High Risk
FEI: 3011853060 • Navi Mumbai, Maharashtra • INDIA
FEI Number
3011853060
Location
Navi Mumbai, Maharashtra
Country
INDIAAddress
R - 904 905 Midc Area Road, , Navi Mumbai, Maharashtra, 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/28/2025 | 64DCL01CARBOXYMETHYLCELLULOSE SODIUM, EMOLLIENT,LUBRICANT | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 3/14/2024 | 64ADY15SODIUM HYPOCHLORITE (SOL) (DISINFECTANT) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 11/18/2023 | 64DBK02POLYETHYLENE GLYCOL, EMOLLIENT,LUBRICANT | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 11/18/2023 | 64DBK02POLYETHYLENE GLYCOL, EMOLLIENT,LUBRICANT | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 11/18/2023 | 64DBK02POLYETHYLENE GLYCOL, EMOLLIENT,LUBRICANT | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 11/18/2023 | 64DAK01CARBOXYMETHYLCELLULOSE SODIUM, EMOLLIENT,LUBRICANT | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 11/18/2023 | 64DAK01CARBOXYMETHYLCELLULOSE SODIUM, EMOLLIENT,LUBRICANT | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 11/18/2023 | 64DBK02POLYETHYLENE GLYCOL, EMOLLIENT,LUBRICANT | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 11/18/2023 | 64DAK01CARBOXYMETHYLCELLULOSE SODIUM, EMOLLIENT,LUBRICANT | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 11/18/2023 | 64DAK01CARBOXYMETHYLCELLULOSE SODIUM, EMOLLIENT,LUBRICANT | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 11/18/2023 | 64DAK01CARBOXYMETHYLCELLULOSE SODIUM, EMOLLIENT,LUBRICANT | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 11/18/2023 | 64DBK01CARBOXYMETHYLCELLULOSE SODIUM, EMOLLIENT,LUBRICANT | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 11/18/2023 | 64DBK01CARBOXYMETHYLCELLULOSE SODIUM, EMOLLIENT,LUBRICANT | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 11/18/2023 | 64DBK01CARBOXYMETHYLCELLULOSE SODIUM, EMOLLIENT,LUBRICANT | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 11/18/2023 | 64DBK01CARBOXYMETHYLCELLULOSE SODIUM, EMOLLIENT,LUBRICANT | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Kilitch Healthcare India Limited's FDA import refusal history?
Kilitch Healthcare India Limited (FEI: 3011853060) has 15 FDA import refusal record(s) in our database, spanning from 11/18/2023 to 10/28/2025.
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. Kilitch Healthcare India Limited's FEI number is 3011853060.
What types of violations has Kilitch Healthcare India Limited received?
Kilitch Healthcare India Limited 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 Kilitch Healthcare India Limited come from?
All FDA import refusal data for Kilitch Healthcare India 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.