An investigation in March 1999 revealed “a serious regulatory problem involving software for [the] Solar Model 7000/8000 Patient Monitors.” The “inspection found that the devices are adulterated within the meaning of Section 501 (h) of the Act in that the methods used in, facilities or controls used for manufacturing, packing, storage, or installation of the medical devices are not in conformance with the Good Manufacturing Practices (GMP) requirements set forth in the Quality System Regulations for Medical Devices as prescribed by Title 21, Code of Federal Regulations (CFR), Part 820. Violations included “failure to establish the appropriate responsibility, authority, and interrelation of all personnel who manage, perform, and assess work affecting quality” and “failure to establish and maintain procedures for validating the device design.”