FDA Inspection With no 483 Findings

Quasar passes FDA inspection with no 483 findings

An FDA inspection was conducted at the Quasar manufacturing facility in Shenzhen, October 31 to November 3, 2016.

This is the second consecutive FDA inspection Quasar passed with ZERO findings (no 483). This result endorses Quasar’s commitment to being a world-class medical device manufacturer.

Consistent with Quasar’s legacy of maintaining high quality standards, we focus on quality throughout the facility, whether in employee training, process development, equipment validations and all phases to manufacturing.

The Impact of Quasar’s Crisis Leadership Through Covid-19

As rumors of Covid-19 spread in January 2020, and fear gripped most of China, the management had to face facts and realize that a serious crisis was in the offing. Instead of being paralyzed by fear and uncertainty, Quasar’s leadership headed by Ayal Amitai, CEO, began looking ahead, considering courses of action to get the plant working again.

A Second Medical Device Manufacturing Source As a Risk Mitigation Strategy

Many supply-chain vulnerabilities stem from long lead times and high levels of cyclicity that prevent the maintenance of the right inventory balance. OEM companies must identify and solve supply-chain vulnerabilities and risk exposures by creating effective mitigation and business-continuity plans.