Amka Products (Pty) Ltd
⚠️ Moderate Risk
FEI: 3003428228 • Centurion, Gauteng • SOUTH AFRICA
FEI Number
3003428228
Location
Centurion, Gauteng
Country
SOUTH AFRICAAddress
14 Ellman Street, , Centurion, Gauteng, South Africa
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
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
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).
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
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).
COLOR LBLG
The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/28/2017 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Division of Northern Border Imports (DNBI) | |
| 3/28/2017 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Division of Northern Border Imports (DNBI) | |
| 3/28/2017 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Division of Northern Border Imports (DNBI) | |
| 8/26/2015 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 3/30/2015 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | Cincinnati District Office (CIN-DO) | |
| 10/30/2009 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 473LABELING | Atlanta District Office (ATL-DO) |
| 10/30/2009 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 473LABELING | Atlanta District Office (ATL-DO) |
| 10/30/2009 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 473LABELING | Atlanta District Office (ATL-DO) |
| 10/30/2009 | 53AC02LOTIONS, OILS, POWDERS AND CREAMS (BABY PRODUCTS) | Atlanta District Office (ATL-DO) |
Frequently Asked Questions
What is Amka Products (Pty) Ltd's FDA import refusal history?
Amka Products (Pty) Ltd (FEI: 3003428228) has 9 FDA import refusal record(s) in our database, spanning from 10/30/2009 to 3/28/2017.
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. Amka Products (Pty) Ltd's FEI number is 3003428228.
What types of violations has Amka Products (Pty) Ltd received?
Amka Products (Pty) Ltd has been cited for 8 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 Amka Products (Pty) Ltd come from?
All FDA import refusal data for Amka Products (Pty) 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.