Product: mixed bed deionization (DI) tanks and carbon tanks that are used to provide treated water to dilute dialysate for use in hemodialysis.
Failure to ensure the device master record includes or refers to the location of the device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications, as required by 21 CFR 820.181(a).
For example, your Device Master Record (DMR) does not include written specifications for the empty DI and carbon tanks, the resin, the carbon or regenerated/filled DI and carbon tanks.
We have reviewed your response and have concluded that it is inadequate because you did not provide documentation indicating that your firm’s DMR has been modified to include, or refers to the location of, your device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications for your regenerated mixed bed DI tanks and carbon tanks.
FDA District:Dallas District Office