FDA 483 - Canadian Hospital Specialties Ltd. - February 02, 2017

An FDA Form 483 was issued to Canadian Hospital Specialties in Oakville, a medical device manufacturer, following an inspection. The report details four observations primarily concerning deficiencies in the firm's quality system. Key issues include inadequate complaint handling procedures, inconsistent device history records, unapproved changes to manufacturing specifications, and insufficient finished device acceptance activities prior to product release.