Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website
Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website
This is a 66.7% decrease from the number of companies cited in the previous year.
The citations in the county include:
- The responsibilities and procedures applicable to the quality control unit are not in writing.
- GMP training is not conducted on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.
- Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
The company cited had to take regulatory and/or administrative actions.
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.
According to its website, 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.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Silliker, Inc. | Drugs | 04/25/2024 | Procedures not in writing, fully followed |
| Silliker, Inc. | Drugs | 04/25/2024 | GMP Training Frequency |
| Silliker, Inc. | Drugs | 04/25/2024 | Computer control of master formula records |
| Silliker, Inc. | Drugs | 04/25/2024 | Scientifically sound laboratory controls |
| Silliker, Inc. | Drugs | 04/25/2024 | Investigations of discrepancies, failures |
Alerts Sign-up