Warning Letter: Failure to validate after design changes (ucm217812)

Failure to establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before there implementation as required by 21 CFR § 820.30(i). Specifically, your firm’s design change request form and design change review form included with your CSO Design Change procedure (procedure includes no signature and date of approval for implementation and no revision history) does not require validation or verification of design changes before there implementation. Your firm has failed to ensure that after the design requirements are established and approved, changes to the design,
both pre-production and post-production are also validated (or verified where appropriate), and approved before implementation.

View the original warning lettter.