Genesis II Church of Health and Healing
⚠️ High Risk
FEI: 3010860149 • Unknown • IRELAND
High Risk
FDA Import Risk Assessment
70.0
LowModerateHighCritical
This firm has a significant history of FDA import refusals with notable violations.
Statistics
127
Total Refusals
5
Unique Violations
8/6/2014
Latest Refusal
6/19/2014
Earliest Refusal
Score Breakdown
Violation Severity
91.4×40%
Refusal Volume
78.0×30%
Recency
0.0×20%
Frequency
100.0×10%
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
75103×
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).
11788×
DANGEROUS
The article appears to be dangerous to health when used in the dosage or manner, or with the frequency or duration, prescribed, recommended, or suggested in the labeling thereof.
1188×
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).
32806×
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.
33401×
DE/RX KIT
The article appears to be a combination medical device/prescription drug kit for which the prescription drug component was manufactured in the U.S., is offered for import by other than the manufacturer, and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/6/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 8/6/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/28/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/28/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/28/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/28/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/28/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/25/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/25/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/25/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/25/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/25/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/25/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/25/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/25/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/25/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/25/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/25/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/25/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/25/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/24/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/24/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/24/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 117DANGEROUS | Cincinnati District Office (CIN-DO) |
| 7/24/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/24/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/23/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/23/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/23/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/23/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/23/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/22/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/22/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/22/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/22/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/22/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/22/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/22/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/22/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/22/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/22/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/22/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/22/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/22/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/22/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/22/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/22/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/22/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/22/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/22/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/22/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/22/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/22/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/22/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/22/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/21/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/21/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 117DANGEROUS | Cincinnati District Office (CIN-DO) |
| 7/21/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 117DANGEROUS | Cincinnati District Office (CIN-DO) |
| 7/21/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/18/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/18/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/18/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/16/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/16/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/16/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/16/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/15/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 117DANGEROUS | Cincinnati District Office (CIN-DO) |
| 7/14/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 3280FRNMFGREG | Cincinnati District Office (CIN-DO) |
| 7/14/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 7/14/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 117DANGEROUS | Cincinnati District Office (CIN-DO) |
| 7/11/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/11/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/11/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/11/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/11/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/11/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/11/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/11/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/11/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/11/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/11/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/11/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/11/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 7/11/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 117DANGEROUS | Cincinnati District Office (CIN-DO) |
| 7/11/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 117DANGEROUS | Cincinnati District Office (CIN-DO) |
| 7/11/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 117DANGEROUS | Cincinnati District Office (CIN-DO) |
| 7/11/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 117DANGEROUS | Cincinnati District Office (CIN-DO) |
| 7/11/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 117DANGEROUS | Cincinnati District Office (CIN-DO) |
| 7/11/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 117DANGEROUS | Cincinnati District Office (CIN-DO) |
| 7/11/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 117DANGEROUS | Cincinnati District Office (CIN-DO) |
| 7/11/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 117DANGEROUS | Cincinnati District Office (CIN-DO) |
| 7/11/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 117DANGEROUS | Cincinnati District Office (CIN-DO) |
| 7/11/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 117DANGEROUS | Cincinnati District Office (CIN-DO) |
| 7/11/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 117DANGEROUS | Cincinnati District Office (CIN-DO) |
| 7/11/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 117DANGEROUS | Cincinnati District Office (CIN-DO) |
| 7/11/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 117DANGEROUS | Cincinnati District Office (CIN-DO) |
| 7/11/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/11/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/11/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/11/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/10/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Genesis II Church of Health and Healing's FDA import refusal history?
Genesis II Church of Health and Healing (FEI: 3010860149) has 127 FDA import refusal record(s) in our database, spanning from 6/19/2014 to 8/6/2014.
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. Genesis II Church of Health and Healing's FEI number is 3010860149.
What types of violations has Genesis II Church of Health and Healing received?
Genesis II Church of Health and Healing has been cited for 5 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 Genesis II Church of Health and Healing come from?
All FDA import refusal data for Genesis II Church of Health and Healing 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.