Afriplex (Pty) Ltd.
⚠️ Moderate Risk
FEI: 3004301175 • Paarl, Western Cape • SOUTH AFRICA
FEI Number
3004301175
Location
Paarl, Western Cape
Country
SOUTH AFRICAAddress
10 De Vreugde Crescent, , Paarl, Western Cape, 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
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).
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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).
UNSFDIETSP
The article appears to be a dietary supplement or ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/4/2017 | 53LC09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Baltimore District Office (BLT-DO) |
| 1/4/2017 | 66VBB99MISCELLANEOUS PATENT MEDICINES, ETC. | Baltimore District Office (BLT-DO) | |
| 1/4/2017 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | Baltimore District Office (BLT-DO) | |
| 1/4/2017 | 66VBC99MISCELLANEOUS PATENT MEDICINES, ETC. | Baltimore District Office (BLT-DO) | |
| 1/4/2017 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | Baltimore District Office (BLT-DO) | |
| 1/4/2017 | 66VPL99MISCELLANEOUS PATENT MEDICINES, ETC. | Baltimore District Office (BLT-DO) | |
| 1/4/2017 | 61XPL99ANTI-HISTAMINIC N.E.C. | Baltimore District Office (BLT-DO) | |
| 1/4/2017 | 61XPL99ANTI-HISTAMINIC N.E.C. | Baltimore District Office (BLT-DO) | |
| 1/4/2017 | 66VPL99MISCELLANEOUS PATENT MEDICINES, ETC. | Baltimore District Office (BLT-DO) | |
| 1/4/2017 | 68HBL20PARASITICIDES (EXTERNAL) USED MORE THAN 1 SPECIES | Baltimore District Office (BLT-DO) | |
| 12/14/2005 | 54FBR99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 2120UNSFDIETSP | Los Angeles District Office (LOS-DO) |
| 11/1/2005 | 66VBR99MISCELLANEOUS PATENT MEDICINES, ETC. | 2120UNSFDIETSP | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Afriplex (Pty) Ltd.'s FDA import refusal history?
Afriplex (Pty) Ltd. (FEI: 3004301175) has 12 FDA import refusal record(s) in our database, spanning from 11/1/2005 to 1/4/2017.
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. Afriplex (Pty) Ltd.'s FEI number is 3004301175.
What types of violations has Afriplex (Pty) Ltd. received?
Afriplex (Pty) Ltd. has been cited for 6 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 Afriplex (Pty) Ltd. come from?
All FDA import refusal data for Afriplex (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.