Company: Total Medical Information Management Systems Inc.
Product: Picture archiving and communications systems software
During an inspection of your establishment located in Longwood, Florida on August 6-7, 2001, FDA Investigator Ronald T. Weber determined that your establishment is a manufacturer and distributor of picture archiving and communication systems software, which is a medical device as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act).
Your firm failed to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30. For example, the software designed by your firm was developed without design controls (FDA 483, Item #2).
Florida District Office