Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website
Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website
This is unchanged from the number of companies cited in the previous quarter.
The citations in the county include:
- The written MDR Procedure does not include an internal system which provides for timely and effective evaluation of events that may be subject to medical device reporting requirements.
- An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
- Risk analysis is inadequate.
The company cited should take a voluntary action to correct its managing operations.
The FDA routinely inspects facilities across the nation to determine if the workplace and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly.
The FDA is a government agency that is primarily responsible for monitoring the production and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety quality, according to its website.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| WalkMed, LLC | Devices | 09/13/2024 | Lack of System for Event Evaluations |
| WalkMed, LLC | Devices | 09/13/2024 | Individual Report of Malfunction |
| WalkMed, LLC | Devices | 09/13/2024 | Design Validation - Risk analysis not performed/inadequate |
| WalkMed, LLC | Devices | 09/13/2024 | Lack of or inadequate complaint procedures |
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