Philips' subsidiary gets FDA CAPA warning
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, recently posted to the agency’s website, also cited the company for procedural, documentation and training violations.
The letter also noted that “failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties.”
Philips’ response to the FDA inspection of Health Watch said the subsidiary is no longer a device manufacturer; however, the agency disagrees.
Royal Philips Electronics acquired Health Watch, a provider of personal emergency services, in April 2007 for approximately $130 million.
Philips has had a slew of recent acquisitions, including Tomcat Systems, Respironics, Visicu, Emergin, Lifeline Systems, Health Watch and Raytel Cardiac Services.