BTL Industries Ltd.
⚠️ Moderate Risk
FEI: 3005694554 • Stevenage, Hertfordshire • UNITED KINGDOM
FEI Number
3005694554
Location
Stevenage, Hertfordshire
Country
UNITED KINGDOMAddress
161 Cleveland Way, , Stevenage, Hertfordshire, 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
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/10/2015 | 74DPSELECTROCARDIOGRAPH | Florida District Office (FLA-DO) | |
| 8/10/2015 | 89IMJDIATHERMY, SHORTWAVE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT | Florida District Office (FLA-DO) | |
| 8/13/2013 | 74DPSELECTROCARDIOGRAPH | Florida District Office (FLA-DO) | |
| 8/13/2013 | 89LPQSTIMULATOR, ULTRASOUND AND MUSCLE, FOR USE OTHER THAN APPLYING THERAPEUTIC DEEP | Florida District Office (FLA-DO) | |
| 8/13/2013 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Florida District Office (FLA-DO) | |
| 9/7/2012 | 74DPSELECTROCARDIOGRAPH | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/7/2012 | 84MWTTHERAPEUTIC NEUROLOGY DEVICE, MAGNET | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/7/2012 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/7/2012 | 89LPQSTIMULATOR, ULTRASOUND AND MUSCLE, FOR USE OTHER THAN APPLYING THERAPEUTIC DEEP | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/7/2012 | 87NBNGENERATOR, SHOCK-WAVE, (FOR PAIN RELIEF) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/22/2011 | 89LPQSTIMULATOR, ULTRASOUND AND MUSCLE, FOR USE OTHER THAN APPLYING THERAPEUTIC DEEP | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/22/2011 | 74DPSELECTROCARDIOGRAPH | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/22/2011 | 84MWTTHERAPEUTIC NEUROLOGY DEVICE, MAGNET | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/22/2011 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is BTL Industries Ltd.'s FDA import refusal history?
BTL Industries Ltd. (FEI: 3005694554) has 14 FDA import refusal record(s) in our database, spanning from 8/22/2011 to 8/10/2015.
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. BTL Industries Ltd.'s FEI number is 3005694554.
What types of violations has BTL Industries Ltd. received?
BTL Industries Ltd. has been cited for 3 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 BTL Industries Ltd. come from?
All FDA import refusal data for BTL Industries 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.