Octapharma Plasma, Inc.March 22, 2024

FDA 483 - Octapharma Plasma, Inc. - March 22, 2024

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An FDA inspection of Octapharma Plasma, Inc. in Dallas, TX, a source plasma center, revealed a significant quality control issue related to equipment calibration. The firm failed to ensure that weights used for plasma collection were calibrated against the proper weight standard, leading to an inability to determine equipment tolerance for critical devices. This lapse indicates a failure to comply with official requirements for equipment performance.

Company: Octapharma Plasma, Inc.
Inspection Date: March 22, 2024
Product Type: Biologics
Office: Division of Human and Animal Food Operations - West III
Person: Ramon L. Gonzalez-Prieto

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ID · 20372d7d-8e3e-4efc-8f53-90b3f7d2fe76