No approval signatures and dates were documented for the Validation Report , [redacted]. The only approval signatures that were documented were that of the [redacted] and [redacted] from Isotron Ireland. 6. Failure to adequately establish and maintain procedures to control all documents to assure that all documents meet the requirements of this part. Those documents should include the signature of the individual(s) approving the documents and shall be documented, as required by 21 CFR 820.40(a).
View the original warning letter.