FDA 483 - Remidio Innovative Solutions Pvt. Ltd. - February 07, 2019

An FDA inspection of Remidio Innovative Solutions Pvt. Ltd. in Bangalore, India, identified an inadequacy in their design change procedures. The firm failed to establish adequate procedures for evaluating changes to their ophthalmic camera to determine if premarket submissions (510(k) or PMA) were required. Additionally, the procedures did not mandate documenting a rationale when verification or validation activities were not performed.