Namandjé N. Bumpus Principal Deputy Commissioner at U.S. Food And Drug Administration (fda) | Official website
Namandjé N. Bumpus Principal Deputy Commissioner at U.S. Food And Drug Administration (fda) | Official website
This is an increase over 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.
- Employees are not given training in the particular operations they perform as part of their function.
- Failure to maintain a backup file of data entered into the computer or related system.
The company cited was involved in the Drugs 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 |
|---|---|---|---|
| Alkermes, Inc. | Drugs | 10/19/2023 | Procedures not in writing, fully followed |
| Alkermes, Inc. | Drugs | 10/19/2023 | Training--operations, GMPs, written procedures |
| Alkermes, Inc. | Drugs | 10/19/2023 | Backup file not maintained |
| Alkermes, Inc. | Drugs | 10/19/2023 | Computer control of master formula records |
| Alkermes, Inc. | Drugs | 10/19/2023 | Validation lacking for sterile drug products |
| Alkermes, Inc. | Drugs | 10/19/2023 | Scientifically sound laboratory controls |
| Alkermes, Inc. | Drugs | 10/19/2023 | Complaints reviewed by Quality Control Unit |
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