Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website
Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website
This is an increase over the number of companies cited in the previous year.
The citations in the county were 'Written procedures are not followed that describe the in-process controls to be conducted on appropriate samples of in-process materials of each batch' and 'Laboratory records are deficient in that they do not include a complete record of all data obtained during testing'.
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 |
|---|---|---|---|
| AstraZeneca Pharmaceuticals LP | Drugs | 09/19/2023 | Written in-process control procedures |
| AstraZeneca Pharmaceuticals LP | Drugs | 09/19/2023 | Complete Test Data |
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