FDA 483 - Analogic Corporation - August 25, 2022

An FDA inspection of Analogic Corporation, a medical device manufacturer located in Peabody, MA, was conducted from August 22 to August 25, 2022. The inspection resulted in one significant observation: the company's device history records failed to demonstrate that specific computed tomography systems were manufactured in accordance with regulatory requirements. Specifically, four device history records for the CTXX85 computed tomography system were reviewed, and none included the necessary primary identification label. Three of these units had already been distributed for human use, and one for veterinary use, highlighting a lapse in critical documentation. This directly contravenes the requirements outlined in 21 CFR 820, the regulatory framework governing quality systems for medical devices, which mandates complete and accurate records for each device. As a result of this observation, Analogic Corporation is required to take corrective action to ensure compliance. The firm provided a commitment during the inspection to rectify this specific issue by September 30, 2022. Furthermore, the FDA emphasizes the company's broader responsibility to conduct thorough internal self-audits to identify and correct any and all violations of quality system requirements to prevent recurrence and ensure ongoing adherence to federal regulations.