Benjamin D. Moncarz Chief Financial Officer - FDA | Official Website
Benjamin D. Moncarz Chief Financial Officer - FDA | Official Website
This is an increase over the number of companies cited in the previous quarter.
The citations in the county include:
- The quality control unit lacks responsibility for approving or rejecting drug products manufactured, processed, packed and held under contract by another company.
- 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.
- Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.
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 |
|---|---|---|---|
| PediFix, Inc. | Drugs | 02/12/2024 | Contract drug products--lack of responsibility |
| PediFix, Inc. | Drugs | 02/12/2024 | Computer control of master formula records |
| PediFix, Inc. | Drugs | 02/12/2024 | Annual visual exams of drug products |
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