Estill Gets 483 Over Monitoring of Contract Manufacturer

Estill Medical Technologies is not adequately monitoring its contract manufacturer to ensure product control after rework to correct nonconformances, according to a recent Form 483. A June 25 to July 3 inspection found the company did not evaluate its contract manufacturers’ ability to meet its quality requirements and had not established a supplier quality document for several major component suppliers for contract manufacturers of its blood and IV fluid infusion warmers.
The GMP Letter