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FDA Taiwan confirmed an uncertified orthopedic implants in hospitals




Their was a Uncertified orthopedic implants used in Taiwan hospitals says Food and Drug Admistration (FDA)


In Taipei, Taiwan there's a reported in CNA that the Taiwanese manufacturer of an orthopedic implant is under investigation for allegedly supplying hospitals with falsely certified products, says by FDA

Ispect Biotech, which makes a plate and screw implant for broken bones, is suspected of falsifying the serial numbers on its products, using the good manufacturing practice (GMP) serial numbers of other certified companies, FDA Director General Wu Shou-mei said.

In the period January to July, 80 hospitals in Taiwan, the FDA head says 80 hospitals, including the National Taiwan University Hospital and Tri-Service General Hospital, procured,The uncertified implants were used on some 70,000 patients.


Implant is under investigation for allegedly supplying hospitals with falsely certified products.
According to administration Director General Wu Shou-mei, Ispect Biotech is suspected of falsifying the serial numbers on its products, using the good manufacturing practice serial numbers of other certified companies. Ispect Biotech makes a plate and screw implant for broken bones.


FDA Division of Risk Management Director Lee Ming-hsin said Ispect Biotech had commissioned two companies to manufacture the implants, allegedly using serial numbers from certified products.

The case has been handed over to prosecutors for further investigation, according to Wu.

The Food and Drug Administration says the manufacturer of an orthopedic, The case has been handed over to prosecutors for further investigation.


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