Balance Healthcare Limited
⚠️ Moderate Risk
FEI: 3004254496 • Chipping Norton, Oxfordshire • UNITED KINGDOM
FEI Number
3004254496
Location
Chipping Norton, Oxfordshire
Country
UNITED KINGDOMAddress
11 Langston Priory Workshops, Station Road, Chipping Norton, Oxfordshire, United Kingdom
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
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).
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).
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.
HEALTH C
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/5/2015 | 54F99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Cincinnati District Office (CIN-DO) | |
| 12/26/2013 | 73BWKSTIMULATOR, ELECTRO-ACUPUNCTURE | Philadelphia District Office (PHI-DO) | |
| 5/23/2013 | 73BWKSTIMULATOR, ELECTRO-ACUPUNCTURE | 118NOT LISTED | Philadelphia District Office (PHI-DO) |
| 3/18/2009 | 66VIC99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 3/18/2009 | 66VIC99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
Frequently Asked Questions
What is Balance Healthcare Limited's FDA import refusal history?
Balance Healthcare Limited (FEI: 3004254496) has 5 FDA import refusal record(s) in our database, spanning from 3/18/2009 to 8/5/2015.
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. Balance Healthcare Limited's FEI number is 3004254496.
What types of violations has Balance Healthcare Limited received?
Balance Healthcare Limited 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 Balance Healthcare Limited come from?
All FDA import refusal data for Balance Healthcare Limited 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.