Denttio’s Los Angeles, Calif., facility was hit with a warning letter for inadequate complaint evaluations and CAPA procedures. Source: The GMP Letter

The most common error companies make when conducting internal audits is to take a confrontational approach when fixing them, according to one compliance expert. Source: The GMP Letter

Beginning Sept. 1, companies that put their names on devices made by other companies must have their quality management systems (QMS) audited and full technical documentation reviewed by notified bodies,…

The European Union’s new Medical Device Regulation (MDR) will create significant compliance headaches for manufacturers — including new harmonized standards, classification rules, and conformity assessment procedures. Source: The GMP Letter

The FDA has issued marketing approval for the first direct-to-consumer genetic tests to assess inherited risks for 10 diseases. Source: The GMP Letter

The FDA’s device center has tripled the number of staff with quality credentials to conduct on-site quality training and inspections. Source: The GMP Letter