483
Haemonetics Manufacturing, Inc.Haemonetics Manufacturing, Inc. – FDA 483, Sep 25, 2019
Record Details
Haemonetics Manufacturing, Inc. in Covina, CA, a drug manufacturer, received a Form 483 with two observations. The inspection revealed significant delays in submitting NDA-Field Alert Reports for drug products failing specifications. Additionally, the firm's quality control unit procedures, specifically the Field Alert Procedure, were found to be outdated and not adequately in writing.
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ID · 6de944ea-ee6e-4ef9-bc53-3939937b3de9
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