India’s Natco Pharma was hit with a Form 483 by the FDA following an inspection that resulted in eight observations. The citation centered on a lack of cleanliness and sterility of equipment plus ...

Troubleshooting is a systematic approach designed to correct problems that may occur with patient samples, instruments, operating an analyzer, handling, reagents and quality control material. The ...

Internal quality control is an integral process of laboratory testing. A clinical laboratory's coagulation quality control (QC) program is a critical component of its quality assessment program. The ...

Regular quality control testing of medical radiological equipment has been shown to improve clinical image quality and reduce patient radiation exposure. Unfortunately is has been largely overlooked ...

Remaining competitive in the medical device market requires the ability to improve quality while reducing costs. Sartorius offers various solutions to improve productivity and meet rigorous compliance ...

Timothy Howes is tired of hearing about product quality—at least the way most owners and operators frame the topic. “If I hear one more restaurant owner say, ‘We serve quality food,’ I think I’m going ...

The Federal Aviation Administration said the agency’s 737 MAX production audit into Boeing and supplier Spirit AeroSystems found multiple instances where the companies allegedly failed to comply with ...

The PCAOB released a new staff report designed to help audit firms remedy quality control issues cited in inspections. The report features advice for firms facing remediation following findings of ...

At GM’s manufacturing facilities, AI-powered technology helps to improve vehicle quality as well as safety and ergonomics for team members. General Motors has recently leveraged the immense know-how ...

India wanted to bring up to 2,500 products under quality control orders, but recently, it has withdrawn orders on many items.