Warning Letter: Failure to Follow Procedures (ucm216889)

Failure to adequately ensure that when the results of a process cannot be fully verified by subsequent inspection and test that the process shall be validated with a high degree of assurance and approved according to established procedure [21 C.F.R. § 820.75(a)]. “Specifically, the procedure “Validation of the Aseptic Filling Process Utilizing the Media Fill Method,”[redacted], states that initial validations should be conducted consecutively and prior to routine production fills and subsequent re-qualifications should be performed [redacted] as appropriate. In addition, the procedure states that routine production may not resume until acceptable qualification or validation runs are achieved or until all appropriate investigations and/or repeat media fills have been performed with acceptable results. However, validation of the aseptic filling process in filling suite [redacted] for [redacted] bottles was inadequate in that the [redacted] re-qualification of the [redacted] Aseptic Filling Process utilizing the Media Fill Method [redacted]performed on March 23, 2009 failed. The failure produced [redacted] contaminated units out of approximately [redacted] units inspected. In addition, the subsequent validation of [redacted] for filling [redacted]and [redacted] bottle [redacted performed on May 20, 2009 also failed.

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