Recipient:Omron Healthcare, Inc.
Product:diagnostic and therapeutic foreign manufactured medical devices
This inspection revealed, that these devices are adulterated within the meaning of Section 501(h) of the Act [21 U.S.C. 351(h)], in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.We address these responses below, in relation to each of the noted violations. These violations include; but are not limited to, the following:
Failure to adequately validate computer software used in an automated process for its intended use according to an established protocol, as required by 21 CFR 820.70(i).
FDA Chicago District Office