Warning Letter: Failure to implement SOP (ucm336120)

Specifically, your firm has no standard operating procedures implemented to determine if the complaint received represents an MDR reportable event.  Your firm documents complaints in a computer system called [redacted]; however, this practice is inadequate because you failed to implement a standard operating procedure… Failure to implement procedures to ensure all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50.  Specifically, your firm failed to define, document, and implement purchasing control procedures to ensure the Nurse Call hardware purchased from your contract manufacturer conforms to your firm’s specified requirements.

• Failure to establish and maintain adequate procedures to control the design of the device in order to ensure specified design requirements are met, as required by 21 CFR 820.30(a)(1).  For example, your firm failed to establish and maintain written procedures to control the design process, including requirements for design inputs, design outputs, design reviews, design verification/validation, design transfer and design changes for the Nurse Call and Focus devices.

View the original warning letter.