Haemonetics Manufacturing, Inc.September 25, 2019

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

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 Additionally, the firm's quality control unit procedures, specifically the Field Alert Procedure, were found to be outdated and not adequately in writing.

Company: Haemonetics Manufacturing, Inc.
Inspection Date: September 25, 2019
Product Type: Drugs
Office: Division of Pharmaceutical Quality Operations IV
People: Elizabeth A. Brown
Marcus F. Yambot (Senior Consumer Safety Officer )

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ID · 6de944ea-ee6e-4ef9-bc53-3939937b3de9