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When the FDA finds the same problems across multiple inspections separated by months or years, it suggests systemic issues with quality management rather than isolated incidents

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Health care professionals and patients should report adverse events or side effects related to the use of this product to FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online MedWatch Online Voluntary Reporting Form, or: Download and complete the form, then submit it via fax at 1-800-FDA-0178