FDA 483 - Orthalign, Inc - May 02, 2017

Orthalign, Inc., a medical device manufacturer in Aliso Viejo, CA, was inspected by the FDA and received a Form 483 with five observations. The inspection revealed significant deficiencies in the firm's quality system, particularly concerning design controls, design verification and validation, corrective and preventive actions, and control of nonconforming material. These issues indicate a lack of adequate procedures and implementation across several critical areas of device manufacturing.