FDA 483 - Haemonetics Manufacturing, Inc. - September 25, 2019

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 Additionally, the firm's quality control unit procedures, specifically the Field Alert Procedure, were found to be outdated and not adequately in writing.