Recipient: Steris Isomedix Inc Product:sterilizes medical devices. Date: 9/25/2008 We have reviewed your response dated July 16, 2008, and have concluded that it is inadequate because while you have opened a Correction and Preventative Action (CAPA) to address this issue, your corrective actions did not address any product that was processed prior to the initiation...Read More
Recipient: Encore Medical, LP Product:muscle stimulators and ultrasound devices. Date: 6/25/2008 1. Failure to establish and maintain adequate procedures to identify actions(s) needed to correct and prevent recurrence of nonconforming product and other quality problems, as required by 21 CFR 820.100(a)(3). For example, your firm failed to identify the action(s) needed to correct failures and...Read More
CSV Training Course
Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email email@example.com for more info.