FDA 483 - DIAMOND ORTHOTIC LABORATORY - November 16, 2023

During an inspection conducted by the U.S. Food and Drug Administration (FDA) from November 13 to November 16, 2023, Diamond Orthotic Laboratory, a medical device manufacturer, received a Form FDA 483 detailing significant observations.

The inspection highlighted several key areas of non-compliance with quality system requirements. Firstly, the firm lacked established procedures for finished device acceptance, failing to ensure proper review of Device Master Record activities, authorized releases, and comprehensive acceptance records. Secondly, material control procedures for manufacturing were inadequate; specifically, the firm did not maintain records for temperature and humidity, nor did it label in-process materials with essential batch/lot numbers and expiration dates. Thirdly, complaint files were not adequately maintained, with missing documented investigations into root causes, unrecorded Medical Device Report (MDR) statuses, and an absence of Unique Device Identification (UDI) information. Finally, the company failed to document personnel training, despite indicating that such training had taken place.

These observations signify a need for Diamond Orthotic Laboratory to enhance its quality management system to comply with federal regulations. The firm has committed to correcting all noted deficiencies, requiring the implementation of robust procedures and comprehensive documentation across its operations.