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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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