Bodyology Institute Of Health
✅ Low Risk
FEI: 3004156458 • Gillitts, Kwazulu-Natal • SOUTH AFRICA
FEI Number
3004156458
Location
Gillitts, Kwazulu-Natal
Country
SOUTH AFRICAAddress
16 Old Main Road, , Gillitts, Kwazulu-Natal, South Africa
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity 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
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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
Frequently Asked Questions
What is Bodyology Institute Of Health's FDA import refusal history?
Bodyology Institute Of Health (FEI: 3004156458) has 2 FDA import refusal record(s) in our database, spanning from 1/10/2012 to 1/10/2012.
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. Bodyology Institute Of Health's FEI number is 3004156458.
What types of violations has Bodyology Institute Of Health received?
Bodyology Institute Of Health has been cited for 2 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 Bodyology Institute Of Health come from?
All FDA import refusal data for Bodyology Institute Of Health 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.