FDA 483 - Oto Med Inc - August 30, 2024

An FDA inspection of Oto Med Inc, a medical device manufacturer in Lake Havasu City, AZ, revealed significant deficiencies across its quality system. Observations included inadequate documentation of corrective and preventive actions, poorly maintained complaint files, and insufficient procedures for device history records. Additionally, the firm failed to adequately validate processes, establish proper quality audit procedures, and ensure purchased products and services conformed to requirements.