Company: Innovative Products Unlimited Inc.
Product: Medical Device products including gurneys
Date: 3/4/03
No procedures to control labeling activities, as required by 21 CFR 820.120. For example, while you maintain master labels for your gurney models, these master labels lack signatures and dates to document that they have been reviewed and approved, and there are no written procedures for examining the incoming labeling of all gurney models against approved master labels to ensure that the labeling is accurate. There are also no written procedures for examining finished product labeling for gurneys, including labels generated using software maintained by your company.
FDA District: Detroit District Office
