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 unchanged from the number of companies cited in the previous quarter.
The citations in the county include:
- The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
- Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
- Written production and process control procedures are not followed in the execution of production and process control functions.
The company cited was involved in the Drugs and Veterinary sectors.
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 |
|---|---|---|---|
| Future Pak, Ltd. | Drugs | 10/15/2024 | Procedures not in writing, fully followed |
| Future Pak, Ltd. | Drugs | 10/15/2024 | Written procedures not established/followed |
| Future Pak, Ltd. | Drugs | 10/15/2024 | SOPs not followed / documented |
| Future Pak, Ltd. | Drugs | 10/15/2024 | Written in-process control procedures |
| Future Pak, Ltd. | Drugs | 10/15/2024 | Following/documenting laboratory controls |
| Future Pak, Ltd. | Drugs | 10/15/2024 | Investigations of discrepancies, failures |
| Future Pak, Ltd. | Veterinary | 10/15/2024 | Procedures not in writing, fully followed |
| Future Pak, Ltd. | Veterinary | 10/15/2024 | Written procedures not established/followed |
| Future Pak, Ltd. | Veterinary | 10/15/2024 | SOPs not followed / documented |
| Future Pak, Ltd. | Veterinary | 10/15/2024 | Written in-process control procedures |
| Future Pak, Ltd. | Veterinary | 10/15/2024 | Following/documenting laboratory controls |
| Future Pak, Ltd. | Veterinary | 10/15/2024 | Investigations of discrepancies, failures |
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