FDAnews Device Daily Bulletin

Biological Controls has been warned for several quality system (QS) and documentation failures, including failure to establish a quality policy or audit procedures. The Eatontown, N.J., company, which makes air purification devices, did not conduct quality audits and management reviews, according to a Feb. 16 warning letter posted last month to the FDA website. It also lacked design control procedures and criteria for evaluating design changes.
The GMP Letter