Medical Concepts Development, Woodbury, MN, Feb. 2 (Minneapolis, MN).(MEDICAL DEVICES)

The manufacturer of surgical drapes was inspected Oct. 25-Nov. 8, and was determined to not be in line with current GMPs.

Deficiencies included failure to implement procedures for CAPAs. Specifically, a corrective action was not initiated to address the problem of bioburden levels exceeding action/alert levels.

Next, the agency wrote, the company failed to document corrective and preventive action activities, including investigations of causes of nonconformities.

Specifically, corrective actions 078, 087, 106, and 146 were incomplete.

Also, the firm did not implement procedures for monitoring and control of process parameters for validated processes.

Specifically, when bioburden levels exceeded the action/alert limits, no action was taken as required by Procedure for Environmental Monitoring.

Failure to validate a process whose results cannot be fully verified by subsequent inspection and test according to established procedures also was noted. Specifically, the Procedure for Validation of Sterilization Processes, QP-25, required annual revalidation of the sterilization process. Re-validation was not performed in 2004.

Next, the company did not investigate complaints involving the possible failure of a device to meet its specifications.

Last, the firm failed to establish process control procedures that describe any process controls necessary to ensure conformance to specifications.

Specifically, procedures that describe the process of packaging non-sterile product into boxes with labels indicating the boxes have undergone the sterilization process were not established to assure that non-sterile devices are not distributed to customers. Val; CAPA; Lab; C-H; Doc. 14107W

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