FDA 483 - Dane Technologies - March 18, 2022

This FDA Form 483 was issued to Dane Technologies, a medical device manufacturer in Maple Grove, MN, following an inspection from March 16-18, 2022. The inspection revealed significant deficiencies in the firm's quality system, specifically concerning management review, internal quality audits, and procedures for servicing activities and complaint handling. These observations indicate a lack of adherence to established quality system requirements.