483
Balassa Laboratories, Inc.Balassa Laboratories, Inc. – FDA 483, Apr 7, 2023
Record Details
An FDA inspection of Balassa Laboratories, Inc. in Port Orange, FL, an OTC drug manufacturer, revealed three significant observations related to current Good Manufacturing Practices. Issues included inadequate handling and storage of components leading to potential cross-contamination, missing execution results for equipment installation and operational qualifications, and a failure to properly identify the status of major manufacturing equipment.
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ID · a343a2ae-99b2-4e89-81e9-6dcd1ab8a1a5
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