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Home » Topics » Medical Devices » QSR

QSR
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FDA Flags Repeat Nonconformities at Zimmer Biomet Facility

March 8, 2018
The FDA posted a Form 483 flagging several GMP and MDR nonconformities — most of which are repeat observations — at a Zimmer Biomet medical device manufacturing facility in Indiana. Read More

FDA Flags Spate of Repeat Nonconformities at Zimmer Biomet Facility

February 12, 2018
The firm’s CAPA procedures and lack of written MDR procedures were among the nonconformities flagged on more than one occasion after FDA inspections. Read More

FDA Flags Spate of Repeat Nonconformities at Zimmer Biomet Facility

February 9, 2018
The FDA issued a Form 483 flagging several GMP and MDR nonconformities — most of which are repeat observations — at a Zimmer Biomet medical device manufacturing facility in Indiana. Read More

CDRH Seeks Participants for Manufacturing and Product Quality Pilot Program

January 19, 2018
CDRH is looking to enroll a total of nine participants in its new pilot program aimed at identifying best practices for quality product manufacturing. Read More

Warning Letter Roundup: FDA Warns Devicemakers in India, Lithuania, Texas

January 18, 2018
Facilities in India, Lithuania and Texas drew warnings from the FDA for a variety of noncompliances, including inadequate validations, designs and device history records. Read More

CDRH Seeks Participants for Manufacturing and Product Quality Pilot Program

January 18, 2018
CDRH is looking to enroll a total of nine participants in its new pilot program aimed at identifying best practices for quality product manufacturing. Read More

FDA Warns Hand Biomechanics Over MDR, GMP Issues

January 5, 2018
Hand Biomechanics Lab, a manufacturer of bone fixation fastener systems in Sacramento, California, was hit with an FDA warning letter for failing to submit MDRs and for GMP nonconformities. Read More

Warning Letter Roundup: Firms in India, Lithuania and Texas Draw Warnings

December 29, 2017
Facilities in India, Lithuania and Texas drew warnings from the FDA for a variety of noncompliances, including inadequate device history records. Read More
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Nurse Assist Distributed Unsterilized IV Saline Syringes, FDA Says

December 28, 2017
The firm’s device history records for its recalled lots did not include the final quantity of products reviewed, approved and released for distribution. Read More

Warning Letter Roundup: Four Firms Draw Warnings for Noncompliance

December 14, 2017
The FDA warned three devicemakers in Germany, The Netherlands and the U.S. for GMP and other violations, including inadequate responses to a Form 483 report. Read More
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Hand Biomechanics Failed to Report Serious Injuries, FDA Says

December 6, 2017
The California company received complaints about patients who required prescription antibiotics for pin site infections developed while being treated with the Digit Widget device. Read More

FDA Warns ProSun Over Failure to Correct Tanning Bed Exposure Time

November 20, 2017
The company’s correction failed to resolve the issue. Read More
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