Wipro GE Healthcare Private Ltd.
⚠️ Moderate Risk
FEI: 1000571342 • Bengaluru, Karnataka • INDIA
FEI Number
1000571342
Location
Bengaluru, Karnataka
Country
INDIAAddress
122 Export Promotional Industrial Park, , Bengaluru, Karnataka, India
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
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).
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.
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/19/2023 | 90JAASYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED | Division of Northern Border Imports (DNBI) | |
| 3/15/2010 | 74DPSELECTROCARDIOGRAPH | 508NO 510(K) | Florida District Office (FLA-DO) |
| 3/15/2010 | 74DPSELECTROCARDIOGRAPH | 508NO 510(K) | Florida District Office (FLA-DO) |
| 2/16/2006 | 90IYICOLLIMATOR, ORTHOVOLTAGE, THERAPEUTIC X-RAY | 476NO REGISTR | New Orleans District Office (NOL-DO) |
| 7/21/2003 | 90MOSCOIL, MAGNETIC RESONANCE, SPECIALTY | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Wipro GE Healthcare Private Ltd.'s FDA import refusal history?
Wipro GE Healthcare Private Ltd. (FEI: 1000571342) has 5 FDA import refusal record(s) in our database, spanning from 7/21/2003 to 1/19/2023.
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. Wipro GE Healthcare Private Ltd.'s FEI number is 1000571342.
What types of violations has Wipro GE Healthcare Private Ltd. received?
Wipro GE Healthcare Private Ltd. has been cited for 4 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 Wipro GE Healthcare Private Ltd. come from?
All FDA import refusal data for Wipro GE Healthcare Private 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.