Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website
Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website
This is an increase over the number of companies cited in the previous year.
The citations in the county include:
- Document control procedures have not been established.
- A process whose results cannot be fully verified by subsequent inspection and test has not been validated according to established procedures.
- Procedures for corrective and preventive action have not been adequately established.
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 |
|---|---|---|---|
| Monarch Molding, Inc. | Devices | 03/27/2024 | Lack of procedures, or not maintained |
| Monarch Molding, Inc. | Devices | 03/27/2024 | Lack of or inadequate process validation |
| Monarch Molding, Inc. | Devices | 03/27/2024 | Lack of or inadequate procedures |
| Monarch Molding, Inc. | Devices | 03/27/2024 | DMR - not or inadequately maintained |
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