Philips Gets CAPA Warning for Recently Acquired Subsidiary

Health Watch, a subsidiary of Philips Lifeline, is the subject of corrective and preventive action (CAPA) warning letter citations as the FDA continues its focus on CAPA system deficiencies.

Following an inspection of its Boca Raton, Fla., plant, the FDA sent Health Watch a warning letter citing CAPA deficiencies. The company, which manufactures the Health Watch Personal Response System, a Class II device, did not establish a CAPA procedure, an internal audit procedure, a management review procedure, a quality policy or a quality plan that defines quality practices, resources and activities, the warning letter said.

The Feb. 29 letter, posted recently to the agency’s website, also cited the company for procedural, documentation and training violations.

Philips’ response to the FDA inspection of Health Watch said the subsidiary is no longer a device manufacturer, but the agency disagrees.

Ian Race, corporate communications manager for Philips Lifeline, said the company is cooperating with the FDA and taking actions to address the citations in the letter, which is available at www.fda.gov/foi/warning_letters/s6694c.pdf.