483
Biofilm, Inc.Biofilm, Inc. – FDA 483, Jun 15, 2023
Record Details
An FDA inspection of BioFilm, Inc. in Vista, CA, a manufacturer, identified two observations. The firm failed to adequately establish procedures for the review and disposition of nonconforming products and did not maintain proper records. Additionally, schedules for equipment maintenance, including logs and reviews, were not adequately established.
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ID · 82030d7c-5d52-4457-917b-8853f1863281
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