FDA 483 - E. Benson Hood Laboratories, Inc. - February 20, 2024

An FDA inspection of E. Benson Hood Laboratories, Inc., conducted from February 8-20, 2024, identified significant deficiencies within the company's quality system. The Form FDA 483 issued to President Lewis Marten outlined four main observations that require the medical device manufacturer to take corrective action to ensure compliance with federal regulations.

Key issues included inadequate procedures for design change. The firm failed to perform design validation, including sterilization validation, for numerous special-order devices like Tracheal T-Tubes and Stoma Stents, some of which had been modified significantly since 1990 without proper reassessment or documentation. Additionally, the company's complaint handling process was found lacking, with four out of four recent complaints, including reports of device component separation and patient infections, not being adequately investigated or documented per internal procedures.

Furthermore, procedures for corrective and preventive actions (CAPA) were insufficient, as five out of nine reviewed CAPAs lacked complete root cause investigations or objective evidence to verify their effectiveness. Finally, the inspection revealed a failure to document critical acceptance activities, such as specific tests and inspections, for special-order and other ENT products, contradicting the firm's own manufacturing procedures across multiple device history records. E. Benson Hood Laboratories, Inc. is responsible for addressing these observations to meet quality system requirements.