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FDA inspection summary in TAG Medical Products Corporation LTD

Post date: 9 March, 2017 TAG Medical Products

To All TAG Medical Customers,

 

This is to inform you that FDA performed a standard field investigation in TAG Medical during the recent 3 days involving 2 investigators.

I am proud to inform you that FDA investigators concluded that TAG Medical has a good quality management system

in compliance with 21 CFR part 820  that enables to release safe products to the market.

 

The following processes and topics were checked in depth:

  • Management review
  • Internal audits
  • Complaints handling
  • MDRs
  • CAPA process
  • Trend analysis
  • Incoming inspection process
  • Material Non conformity process
  • Design Control – go through entire design project from A to Z and even more…
  • ECO process
  • Recall process
  • UDI process
  • Labels (including IFU)
  • Process validation – demonstration of detailed IQ , OQ , PQ.
  • Clean room control
  • DHRs
  • DMRs
  • ETO sterilization
  • Supplier qualification
  • Software validation

TAG Medical will continue  to strive for perfection and innovation along with high product quality and safety.

Respectfully,

Shlomi Dines | QA & RA Director

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