Estill Gets 483 Over Monitoring of Contract Manufacturer

October 18, 2013
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