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 month.
The citations in the county include:
- Procedures for management review have not been adequately established.
- Procedures for quality audits have not been adequately established.
- Personnel training is not documented.
The company cited was involved in the Devices 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.
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 |
---|---|---|---|
OMT, LLC | Devices | 03/05/2025 | Management review - Lack of or inadequate procedures |
OMT, LLC | Devices | 03/05/2025 | Quality audits - Lack of or inadequate procedures |
OMT, LLC | Devices | 03/05/2025 | Training records |
OMT, LLC | Devices | 03/05/2025 | Design validation- Lack of or inadequate procedures |
OMT, LLC | Devices | 03/05/2025 | Purchasing controls, Lack of or inadequate procedures |
OMT, LLC | Devices | 03/05/2025 | Environmental control Lack of or inadequate procedures |
OMT, LLC | Devices | 03/05/2025 | Documentation |
OMT, LLC | Devices | 03/05/2025 | Lack of or inadequate procedures |