Serendipity Toiletries Pty Ltd
⚠️ Moderate Risk
FEI: 3008721434 • Pretoria, Gauteng • SOUTH AFRICA
FEI Number
3008721434
Location
Pretoria, Gauteng
Country
SOUTH AFRICAAddress
309 Battery Street, , Pretoria, 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
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
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).
Refusal History
Frequently Asked Questions
What is Serendipity Toiletries Pty Ltd's FDA import refusal history?
Serendipity Toiletries Pty Ltd (FEI: 3008721434) has 1 FDA import refusal record(s) in our database, spanning from 12/17/2012 to 12/17/2012.
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. Serendipity Toiletries Pty Ltd's FEI number is 3008721434.
What types of violations has Serendipity Toiletries Pty Ltd received?
Serendipity Toiletries Pty Ltd has been cited for 4 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 Serendipity Toiletries Pty Ltd come from?
All FDA import refusal data for Serendipity Toiletries 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.