Ken Prima Cosmeceuticals, Sdn. Bhd.
⚠️ High Risk
FEI: 3010026101 • Perai, Pulau Pinang • MALAYSIA
FEI Number
3010026101
Location
Perai, Pulau Pinang
Country
MALAYSIAAddress
Plot 22, Lorong Perusahaan Maju 2, Prai Industrial Estate Phase 4, Perai, Pulau Pinang, Malaysia
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).
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
COLOR LBLG
The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/17/2024 | 62WAL17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 7/17/2024 | 62WAL17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 7/1/2024 | 62WAL17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 6/21/2024 | 62WBQ17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 3/31/2017 | 53AD01BABY SHAMPOO (BABY PRODUCTS) | 197COSM COLOR | Division of West Coast Imports (DWCI) |
| 3/31/2017 | 53AD01BABY SHAMPOO (BABY PRODUCTS) | 197COSM COLOR | Division of West Coast Imports (DWCI) |
| 3/31/2017 | 53AD01BABY SHAMPOO (BABY PRODUCTS) | 197COSM COLOR | Division of West Coast Imports (DWCI) |
| 3/30/2017 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 198COLOR LBLG | Division of Southeast Imports (DSEI) |
| 3/30/2017 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 198COLOR LBLG | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Ken Prima Cosmeceuticals, Sdn. Bhd.'s FDA import refusal history?
Ken Prima Cosmeceuticals, Sdn. Bhd. (FEI: 3010026101) has 9 FDA import refusal record(s) in our database, spanning from 3/30/2017 to 7/17/2024.
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. Ken Prima Cosmeceuticals, Sdn. Bhd.'s FEI number is 3010026101.
What types of violations has Ken Prima Cosmeceuticals, Sdn. Bhd. received?
Ken Prima Cosmeceuticals, Sdn. Bhd. has been cited for 3 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 Ken Prima Cosmeceuticals, Sdn. Bhd. come from?
All FDA import refusal data for Ken Prima Cosmeceuticals, Sdn. Bhd. 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.