Benjamin D. Moncarz Chief Financial Officer - FDA | Official Website
Benjamin D. Moncarz Chief Financial Officer - FDA | Official Website
This is unchanged from the number of companies cited in the previous year.
The citations in the county include:
- You did not take a reasonable measure or precaution related to personnel practices.
- You did not review your process preventive control verification records.
- Investigations of an unexplained discrepancy and a failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy.
Both companies cited should take voluntary actions to correct their 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 |
---|---|---|---|
CMP Pharma, Inc. | Drugs | 09/01/2023 | Extent of discrepancy, failure investigations |
Harvest Time Foods, Inc. | Food and Cosmetics | 04/06/2023 | Personnel |
Harvest Time Foods, Inc. | Food and Cosmetics | 04/06/2023 | Process preventive controls - Record review |