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 quarter.
The citations in the county include:
- Deviations from written production and process control procedures are not recorded and justified.
- Written procedures are not established and followed for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected.
- The batch production and control records are deficient in that they do not include a statement of the actual yield and percentage of theoretical yield.
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 |
|---|---|---|---|
| MSI Express, Inc. | Drugs | 01/16/2025 | Procedure Deviations Recorded and Justified |
| MSI Express, Inc. | Drugs | 01/16/2025 | Review of representative number of batches |
| MSI Express, Inc. | Drugs | 01/16/2025 | Documentation of Actual Yield and Theoretical Yield |
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