FDA 483 - PETNET Solutions, Inc. - May 21, 2021
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This FDA Form 483 was issued to PETNET Solutions, Inc. in Jacksonville, FL, a Positron Emission Tomography Drug Manufacturer. The inspection revealed significant deficiencies in quality control, including a lack of procedures for final product release based on laboratory data review and issues with electronic batch record audit trails. Additionally, the firm failed to properly handle and store components, leading to concerns about contamination control in aseptic processing areas.
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