FDA 483 - E.M. Adams Co., Inc. - November 14, 2022

An FDA inspection of E.M. Adams Co., Inc., a medical device manufacturer in Fort Pierce, FL, was conducted from November 7-14, 2022. The inspection resulted in a Form FDA 483, citing four significant observations related to deficiencies in the company's quality management system, essential for medical device manufacturing compliance.

The primary issues identified included inadequate procedures for corrective and preventive actions (CAPA). Specifically, the firm's existing CAPA procedure failed to establish methods for correcting or preventing quality problems, and there was a notable absence of root cause investigations for issues arising from complaints, non-conformities, or audits. The company also lacked documentation for investigations into non-conformities and failed to track in-process non-conformities.

Further observations revealed that E.M. Adams Co. had not established formal procedures for receiving, reviewing, and evaluating customer complaints in a timely manner. Procedures for controlling products that do not conform to specified requirements were also found to be missing, particularly concerning the production of surgical trays. Lastly, the inspection highlighted a lack of established document control procedures to ensure that critical documents are created, reviewed, distributed, and managed in an organized and verifiable way.

These findings indicate a need for the company to significantly improve its adherence to quality system requirements. E.M. Adams Co. has committed to correcting all identified deficiencies to ensure compliance with regulatory standards.