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Your CAPA review board is responsible for monitoring this data to ensure it is meeting your pre-established specifications.

During the inspection, we observed that you are monitoring your interim cleaning processes by requiring testing for (b)(4) (i.e., cleanliness tests).

CAPA CA-03092, was opened on Decemto address inadequate process validations and process control procedures for in-process and final cleaning operations that were revealed during the previous inspection.

During the inspection, review of three separate CAPA’s revealed that your firm has not been able to demonstrate that the corrective or preventive actions taken by your firm are effective in ensuring that devices being distributed meet all finished product specifications. Failure to establish and maintain procedures for verifying or validating the corrective and preventive action, to ensure that such action is effective and does not adversely affect the finished device, as required by 21 CFR 820.100(a)(4).