Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website
Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website
This is an increase over the number of companies cited in the previous quarter.
The citations in the county include:
- The design history file does not demonstrate that the design was developed following the approved design plan.
- Procedures to control environmental conditions have not been adequately established.
- Software used as part of production and the quality system has not been adequately validated for its intended use according to an established protocol.
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 |
|---|---|---|---|
| Visionary Optics, LLC | Devices | 05/17/2024 | Design history file |
| Visionary Optics, LLC | Devices | 05/17/2024 | Environmental control Lack of or inadequate procedures |
| Visionary Optics, LLC | Devices | 05/17/2024 | Software validation for automated processes |
| Visionary Optics, LLC | Devices | 05/17/2024 | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| Visionary Optics, LLC | Devices | 05/17/2024 | Lack of or inadequate procedures |
| Visionary Optics, LLC | Devices | 05/17/2024 | Evaluation, timeliness, identification |
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