Kim Chemicals Private Ltd.
⚠️ High Risk
FEI: 3006370331 • Raigad, Maharashtra • INDIA
FEI Number
3006370331
Location
Raigad, Maharashtra
Country
INDIAAddress
Plot No. G-13/16, Midc, Taloja, , Taloja, Raigad, 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 |
|---|---|---|---|
| 10/18/2017 | 60LAJ99ANALGESIC, N.E.C. | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
| 10/18/2017 | 60LAJ99ANALGESIC, N.E.C. | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
| 10/18/2017 | 66VAJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
| 10/18/2017 | 53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
| 10/18/2017 | 53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
| 10/18/2017 | 53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
| 10/18/2017 | 53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
| 10/18/2017 | 66VAJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Kim Chemicals Private Ltd.'s FDA import refusal history?
Kim Chemicals Private Ltd. (FEI: 3006370331) has 8 FDA import refusal record(s) in our database, spanning from 10/18/2017 to 10/18/2017.
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. Kim Chemicals Private Ltd.'s FEI number is 3006370331.
What types of violations has Kim Chemicals Private Ltd. received?
Kim Chemicals 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 Kim Chemicals Private Ltd. come from?
All FDA import refusal data for Kim Chemicals 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.