Lifescan Inc
⚠️ Moderate Risk
FEI: 2939301 • Malvern, PA • UNITED STATES
FEI Number
2939301
Location
Malvern, PA
Country
UNITED STATESAddress
20 Valley Stream Pkwy, , Malvern, PA, United States
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
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).
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.
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.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
NO PMA/PDP
The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/29/2015 | 75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | Division of Southeast Imports (DSEI) | |
| 12/17/2014 | 75CGAGLUCOSE OXIDASE, GLUCOSE | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 9/13/2013 | 75CGAGLUCOSE OXIDASE, GLUCOSE | Florida District Office (FLA-DO) | |
| 2/27/2012 | 75CGAGLUCOSE OXIDASE, GLUCOSE | 2780DEVICEGMPS | Florida District Office (FLA-DO) |
| 7/7/2011 | 78NTZSTRIP, DIALYSATE, PH, BICARBONATE, GLUCOSE, ACID, INDICATOR | 16DIRECTIONS | New York District Office (NYK-DO) |
| 11/5/2010 | 75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | 341REGISTERED | New York District Office (NYK-DO) |
| 11/5/2010 | 75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | 341REGISTERED | New York District Office (NYK-DO) |
| 5/15/2009 | 75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | 336INCONSPICU | New York District Office (NYK-DO) |
| 11/26/2008 | 75CGAGLUCOSE OXIDASE, GLUCOSE | Florida District Office (FLA-DO) | |
| 6/18/2007 | 75CGAGLUCOSE OXIDASE, GLUCOSE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 4/26/2007 | 75CGAGLUCOSE OXIDASE, GLUCOSE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 11/15/2006 | 75CGAGLUCOSE OXIDASE, GLUCOSE | 508NO 510(K) | Florida District Office (FLA-DO) |
| 12/12/2005 | 88LDTREAGENT, GENERAL PURPOSE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 9/8/2005 | 81LOQDEVICE, GENERAL PURPOSE HEMATOLOGY | 341REGISTERED | Seattle District Office (SEA-DO) |
| 8/4/2005 | 75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | New York District Office (NYK-DO) | |
| 6/2/2005 | 75CGAGLUCOSE OXIDASE, GLUCOSE | Florida District Office (FLA-DO) | |
| 10/23/2004 | 75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | 341REGISTERED | Cincinnati District Office (CIN-DO) |
| 4/27/2004 | 75CGAGLUCOSE OXIDASE, GLUCOSE | 16DIRECTIONS | Division of Southeast Imports (DSEI) |
| 4/8/2004 | 75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | 118NOT LISTED | Florida District Office (FLA-DO) |
| 3/12/2004 | 75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | Florida District Office (FLA-DO) | |
| 3/12/2004 | 75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | Florida District Office (FLA-DO) | |
| 2/11/2004 | 75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | Florida District Office (FLA-DO) | |
| 1/30/2004 | 75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Lifescan Inc's FDA import refusal history?
Lifescan Inc (FEI: 2939301) has 23 FDA import refusal record(s) in our database, spanning from 1/30/2004 to 6/29/2015.
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. Lifescan Inc's FEI number is 2939301.
What types of violations has Lifescan Inc received?
Lifescan Inc has been cited for 8 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 Lifescan Inc come from?
All FDA import refusal data for Lifescan Inc 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.