James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website
James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website
This is unchanged from the number of companies cited in the previous month.
The citations in the county include:
- The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
- GMP training is not conducted on a continuing basis to assure that employees remain familiar with CGMP requirements applicable to them.
- Separate or defined areas to prevent contamination or mix-ups are deficient regarding laboratory controls and operations.
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 |
|---|---|---|---|
| Micra Biotechnologies, Inc. | Drugs | 08/02/2024 | Procedures not in writing, fully followed |
| Micra Biotechnologies, Inc. | Drugs | 08/02/2024 | GMP Training Frequency |
| Micra Biotechnologies, Inc. | Drugs | 08/02/2024 | Control / Lab Operations Area |
| Micra Biotechnologies, Inc. | Drugs | 08/02/2024 | Following/documenting laboratory controls |
| Micra Biotechnologies, Inc. | Drugs | 08/02/2024 | Scientifically sound laboratory controls |
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