Phillips Respironics, Inc. – FDA Warning Letter, Apr 15, 2014

On June 30, 2014, the FDA issued a Warning Letter to Philips Respironics, Inc. following an inspection from April 8-15, 2014, at their Murrysville, Pennsylvania facility. The inspection determined that the firm manufactures the Smart Monitor 2 Apnea Monitor, classified as a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act. The device was found to be adulterated under section 501(h) of the Act, as manufacturing, packing, storage, or installation methods, facilities, or controls did not conform to the Quality System Regulation (21 CFR Part 820).

Violations included: 1. Failure to ensure purchased products conform to specified requirements (21 CFR 820.50). Specifically, the firm accepted and released SM2PS battery packs (lot # (b)(4) and (b)(4)) without visual examination or functionality tests. These battery packs were incorrectly (b)(4), leading to SmartMonitor failures, constant alarming, and inability to continuously monitor infant and pediatric patients. 2. Failure to control production processes to ensure device conformity (21 CFR 820.70). Functionality tests and/or visual examinations were not performed on battery pack components. Additionally, (b)(4) of these battery packs were incorrectly (b)(4) and used in