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...Read More

http://www.fda.gov/cdrh/ode/homenst.htmlRead More