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 year.
The citations in the county include:
- Procedures for training and identifying training needs have not been adequately established.
- Procedures have not been adequately established to control product that does not conform to specified requirements.
- Procedures for corrective and preventive action have not been adequately established.
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 |
|---|---|---|---|
| JAC Custom Pouches, Inc. | Devices | 02/01/2023 | Training - Lack of or inadequate procedures |
| JAC Custom Pouches, Inc. | Devices | 02/01/2023 | Nonconforming product, Lack of or inadequate procedures |
| JAC Custom Pouches, Inc. | Devices | 02/01/2023 | Lack of or inadequate procedures |
| JAC Custom Pouches, Inc. | Devices | 02/01/2023 | DHR content |
| JAC Custom Pouches, Inc. | Devices | 02/01/2023 | Records of complaint investigation |
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