The Food and Drug Administration (FDA) inspected BioAnalysis, LLC in Philadelphia on January 26, 2024, focusing on drug quality assurance. The inspection led to the issuance of two citations to the company, according to data posted on the FDA’s website.
The FDA website indicates that the citations were delivered to the company as follows:
- ‘Changes to written procedures are not reviewed and approved by the quality control unit.’
- ‘There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.’
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 and quality.
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
