IRIS software program.
During a Food and Drug Administration (FDA) inspection of your firm located in Frederick, Maryland, on March 23 and 26, 1997, our Investigator determined that your firm manufactures the IRIS software program used for calculating bone density, which is a device as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act).
1. Failure to maintain a complete Device Master Record (DMR). For example, the DMR did not include approved specifications and procedures for the manufacturing, components, quality assurance, packaging, labeling, and finished product release testing for the IRIS software program [21 CFR 820.181].
2. Failure to document and control changes made to the manufacturing specifications or source code to assure that the device conforms to its original design-[21 CFR 820.100(a)(2)]. For example, you did not document the reason for a software upgrade from version 2.03 to 2.04.
3. Failure to maintain Device History Records for the validation and release testing of the finished device [21 CFR 820.160]. For example, no written records were available to show that testing was conducted to insure that the IRIS software program functioned properly prior to distribution.