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One complaint related to a guidewire that stuck to a stent during a cystoscopy procedure, and another involved the failure of a grip that required replacement of the device during surgery. Read More
Failure to validate reprocessing instructions for its Class II reusable menstrual cups and a host of other quality issues landed Dot International a seven-item Form 483 following an FDA inspection of its Evanston, Illinois facility. Read More
Failure to submit medical device reports to the FDA within the prescribed timeframe and lax complaint handling landed duodenoscope maker Olympus a Form 483 following an FDA inspection of its San Jose, California facility. Read More
An FDA inspection of Harmonic Energetic Technologies’ Liverpool, New York facility revealed that the firm lacked numerous quality management systems. Read More
Validation failures, lax corrective and preventive action (CAPA) procedures, and failure to control product were just a few of the deficiencies uncovered during an FDA inspection of contract manufacturer Relucent Plastic Solutions in Erie, Colorado. Read More
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