DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website
DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the 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.
- Specific identification tests are not conducted on components that have been accepted based on the supplier's report of analysis.
- Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
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.
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 |
---|---|---|---|
Central Solutions, Inc. | Drugs | 04/02/2025 | Procedures not in writing, fully followed |
Central Solutions, Inc. | Drugs | 04/02/2025 | Component identification test |
Central Solutions, Inc. | Drugs | 04/02/2025 | Absence of Written Procedures |
Central Solutions, Inc. | Drugs | 04/02/2025 | Microbiological testing |
Central Solutions, Inc. | Drugs | 04/02/2025 | Valid stability test methods |
Central Solutions, Inc. | Drugs | 04/02/2025 | Investigations of discrepancies, failures |
Central Solutions, Inc. | Veterinary | 04/02/2025 | Procedures not in writing, fully followed |
Central Solutions, Inc. | Veterinary | 04/02/2025 | Component identification test |
Central Solutions, Inc. | Veterinary | 04/02/2025 | Absence of Written Procedures |
Central Solutions, Inc. | Veterinary | 04/02/2025 | Microbiological testing |
Central Solutions, Inc. | Veterinary | 04/02/2025 | Valid stability test methods |
Central Solutions, Inc. | Veterinary | 04/02/2025 | Investigations of discrepancies, failures |