Roche Diagnostics Operations, Inc.
⚠️ Moderate Risk
FEI: 1823260 • Indianapolis, IN • UNITED STATES
FEI Number
1823260
Location
Indianapolis, IN
Country
UNITED STATESAddress
9115 Hague Rd, , Indianapolis, IN, 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
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).
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.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
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).
LBLG ADVER
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded because its labeling is misleading in a particular, namely that it fails to reveal facts (non-sterility) that are material with respect to consequences which may result from the use of the article according to the labeling, or advertising, or under such conditions of use as are customary or usual.
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.
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 |
|---|---|---|---|
| 5/8/2015 | 75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | Cincinnati District Office (CIN-DO) | |
| 3/14/2012 | 75LFRGLUCOSE DEHYDROGENASE, GLUCOSE | Detroit District Office (DET-DO) | |
| 10/18/2011 | 75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | 333LACKS FIRM | New Orleans District Office (NOL-DO) |
| 10/18/2011 | 83JTODISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION | 123BANNED | New Orleans District Office (NOL-DO) |
| 5/16/2005 | 75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | New York District Office (NYK-DO) | |
| 5/16/2005 | 75LFRGLUCOSE DEHYDROGENASE, GLUCOSE | New York District Office (NYK-DO) | |
| 5/16/2005 | 75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | New York District Office (NYK-DO) | |
| 12/22/2004 | 75LFRGLUCOSE DEHYDROGENASE, GLUCOSE | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 10/23/2004 | 75LFRGLUCOSE DEHYDROGENASE, GLUCOSE | Cincinnati District Office (CIN-DO) | |
| 8/19/2004 | 75LFRGLUCOSE DEHYDROGENASE, GLUCOSE | Florida District Office (FLA-DO) | |
| 5/1/2003 | 80MDSSENSOR, GLUCOSE, INVASIVE | New England District Office (NWE-DO) | |
| 1/16/2003 | 75LFRGLUCOSE DEHYDROGENASE, GLUCOSE | Division of Southeast Imports (DSEI) | |
| 5/29/2002 | 75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | New York District Office (NYK-DO) | |
| 5/14/2002 | 80LDQDEVICE, GENERAL MEDICAL | 341REGISTERED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Roche Diagnostics Operations, Inc.'s FDA import refusal history?
Roche Diagnostics Operations, Inc. (FEI: 1823260) has 14 FDA import refusal record(s) in our database, spanning from 5/14/2002 to 5/8/2015.
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. Roche Diagnostics Operations, Inc.'s FEI number is 1823260.
What types of violations has Roche Diagnostics Operations, Inc. received?
Roche Diagnostics Operations, 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 Roche Diagnostics Operations, Inc. come from?
All FDA import refusal data for Roche Diagnostics Operations, 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.