We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Failure to implement procedures for reviewing and evaluating complaints, among other quality system lapses landed Peripheral Visions a Form 483 following an inspection of its Black Diamond, Washington facility. Read More
The FDA has cracked down on more companies trying to take advantage of the COVID-19 pandemic, issuing warning letters to four firms that sold unapproved COVID-19 tests online for use in patients’ homes. Read More
The agency said it is taking urgent steps to protect consumers from products that, “without approval, clearance or authorization by the FDA, claim to mitigate, prevent, treat, diagnose or cure COVID-19.” Read More
FDA inspections at four U.S. facilities revealed problems with design controls, medical device reporting, and corrective and preventive actions. Read More
FDA Commissioner Stephen Hahn said that the agency is resuming domestic inspections using a new risk assessment system developed in response to the pandemic. Read More
Repackager and relabeler 180 Innovations failed to establish procedures for receiving, reviewing and evaluating complaints or for rework of nonconforming product, according to a Form 483 the firm received following an inspection of its Lakewood, Colorado plant. Read More
Failure to maintain and implement written medical device reporting procedures, complaint handling procedures and procedures for controlling nonconforming products were among the quality system failures uncovered during an FDA inspection of Neuromonics’ Westminster, Colorado facility. Read More
Failure to implement procedures for corrective and preventive actions (CAPAs) and to ensure the accuracy of test/measurement equipment coupled with missing documentation for device history records landed Northwest Eye Design a 483 following an inspection of its Kirkland, Washington facility. Read More
Centurion Medical Products received an FDA warning letter for selling unapproved combination test kits following FDA inspections at the firm’s Howell, Michigan facility Aug. 5-20, 2019, and its Williamston, Michigan facility Oct. 21 to Nov. 1, 2019. Read More
The FDA issued a warning letter to Modern Allergy Management doing business as Direct Med Solutions in Milton, Florida for selling COVID-19 test kits for at-home use. The test kits are considered adulterated and misbranded products, the agency said. Read More
RSS
