Compliance Corner: Investigator Gives 7 Tips To Ensure Device Cleanliness, Cleaning Validation
The US FDA’s Tom Peter offers advice, from determining a company’s “worst-case device” to identifying contaminants that work their way into the manufacturing process – and more.
You may also be interested in...
Device makers presented with an affidavit by the US FDA during a facility inspection should walk away as quickly as possible, King & Spalding partner Jessica Ringel advises.
The US agency has announced two additional webinars aimed at labs and manufacturers that are developing – or have developed – diagnostic tests for the coronavirus.
A May recall of 25,000 Super Torque MB Angiographic Catheters with Radiopaque Marker Bands was given the high-risk classification by the US agency on 22 September.