Failure to establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria; failure to establish and maintain an adequate organization structure; and failure of the device master record to include, or refer to the location of, for each type of device, device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications.
3. Failure of the device master record to include, or refer to the location of, for each type of device, device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications, as required by 21 CFR 820.181(a). This would also be a violation of the GMP regulations under 21 CFR 820.181(a). For example:
