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

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

Process control procedures were found to be lax during an FDA inspection of Hudson Scientific’s Hudson, Michigan 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