WARN 09/06/96 NIDEK CO., LTD.
Our investigator determined that your firm manufactures sterile and non-sterile products which include ophthalmological, optometrical, semiconductor measurement equipment, and intra-ocular lense.
2. Failure to prepare and implement quality assurance procedures adequate to assure that a formally established and documented quality assurance program is performed. For example: a) The firm has no software quality assurance plan for software developed in-house for controlling YC-1400 and CV-12000 devices; b) There are no software requirements or design specifications; c) Testing of software changes is purely functional.