FDA 483 - Aeton Medical - August 09, 2023

During an FDA inspection from July 24, 2023, to August 9, 2023, at Aecton Medical, a medical device manufacturer located at 7115 Airport Hwy, Pennsauken, NJ, three observations were noted. Robert Kramer, President/CEO, was issued the report.

Observation 1: The device history record (DHR) did not demonstrate that devices were manufactured in accordance with specifications. Specifically, DHRs for healing caps (e.g., part numbers BNCH 482, BRBH 505, BNCH 656, BNCH 365) lacked documentation of packaging, labeling, and final device release. Additionally, DHRs for healing caps did not include a device history record checklist for each lot from the contract manufacturer; only the most recent checklist was maintained (e.g., part number BRBH 505).

Observation 2: A device master record (DMR) has not been maintained. Specifically, the DMR for healing caps (e.g., part number BRBH656) did not include procedures and specifications for packaging and labeling.

Observation 3: Procedures for corrective and preventive action (CAPA) have not been adequately established. For instance, CAPA 22-001, opened on June 16, 2022, to address a missing approval signature and date on