TendieTensor TendieTensor
You’re browsing as
Guest
Free Preview
Sign in/sign up to unlock all features.

News  ›  Benzinga

Philips Ultrasound Devices Deemed Adulterated Over Manufacturing And Oversight Lapses

Benzinga Logo Benzinga By Vandana Singh
Philips Ultrasound Devices Deemed Adulterated Over Manufacturing And Oversight Lapses

The FDA found Philips manufacturing facilities in multiple locations produced adulterated medical devices due to significant lapses in manufacturing, storage, and quality control practices, including inadequate complaint handling and design validation issues.

Insights
PHG   negative

Multiple regulatory violations identified by FDA, including non-compliance with Good Manufacturing Practices, inadequate complaint handling, design validation shortcomings, and incomplete corrective actions. Stock price dropped 5.85% following the report.