FDA Hands Philips Lengthy Warning for CAPA, GMP Issues

Philips Medical Systems, a subsidiary of imaging devicemaker Philips Healthcare, was cited for various GMP shortfalls, including corrective and preventive action (CAPA) issues, in a recent FDA warning letter. An FDA inspection resulted in 16 citations for the company’s Cleveland site, including failure to establish and maintain adequate CAPA procedures, according to the June 7 letter.
The GMP Letter