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 month.
The citations in the county include:
- No management representative had been appointed to ensure that quality system requirements are met, and to report to management on the performance of the quality system.
- A quality plan has not been established.
- Procedures for quality audits have not been established.
The company cited was involved in the Devices sector.
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 |
|---|---|---|---|
| General Hospital Supply Corporation | Devices | 04/03/2024 | Management representative |
| General Hospital Supply Corporation | Devices | 04/03/2024 | Quality plan |
| General Hospital Supply Corporation | Devices | 04/03/2024 | Quality audits - Lack of or inadequate procedures |
| General Hospital Supply Corporation | Devices | 04/03/2024 | Design control - no procedures |
| General Hospital Supply Corporation | Devices | 04/03/2024 | Lack of or inadequate procedures |
| General Hospital Supply Corporation | Devices | 04/03/2024 | Lack of or inadequate procedures for labeling |
| General Hospital Supply Corporation | Devices | 04/03/2024 | Control number {see also 820.65, 820.184(f)} |
| General Hospital Supply Corporation | Devices | 04/03/2024 | Records of complaint investigation - UDI |
| General Hospital Supply Corporation | Devices | 04/03/2024 | Statistical techniques - Lack of or inadequate procedures |
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