Device manufacturer written up for validation process procedures in 11-item 483.

The Electrode Store, Buckley, WA, Bothell, WA, District

The Electrode Store, a medical device manufacturer in Buckley, WA, was written up in an 11-item 483 because procedures were not implemented for monitoring and control of process parameters for validated processes. A Nov. 23, 2005, warning letter also was issued.

Investigator Dennis Kawabata from the Bothell, WA, District Office conducted the audit. The EIR was not available at press time.

The 483 stated: "For the sterilization process, the following from the validation report Lab No. 04C_39003_01 has not been performed: dose mapping of routine production loads has not been performed as specified in the validation report to demonstrate the degree of process control required for dosimetric release of sterilized products."

The company replied in writing on Dec. 9, 2005: "The sterilization validation testing is under way and we expect to have initial results by Dec. 16, with the final report being issued some time in January 2006."

Also, the report stated that verification dose audits were not conducted periodically to substantiate the continued validity of an undisclosed dose as an SAL dose.

Next, a process whose results cannot be fully verified by subsequent inspection and test was not fully validated and approved according to established procedures.

For example, "there is no documented verification of product performance following sterilization at the maximum allowed dose," the report stated.

Further, acceptance procedures to ensure that specified requirements for in-process product were not established. Specifically, the report stated, "the pull tests in the Work Instructions for the DTM-Series and the PRO-Series Monopolar Disposable Needles are not measurable or repeatable as to the exact amount of pulling to be considered acceptable."

Also, "there is no documented data to demonstrate that the in-process electrical testing of coated needles will ensure that specified requirements are met and can effectively verify the needle coating process," the report added.

Next, statistical techniques were not used for control where statistical techniques were applicable. "Specifically, the sampling described in the work instructions for the DTM-Series and PRO-Series Monopolar Disposable needles for checking the needle and wire assembly was not based on a valid statistical rationale," the 483 stated.

The company responded: "Statistical techniques were put in place prior to Kawabata conducting his inspection, for the pull test on the needles."

Also faulty were the company's CAPAs, which did not address implementations and recording of changes in methods and procedures to correct and prevent identified quality problems. For example, the 483 added, "CAPA 2004-001 has an Effectiveness Check sign off date of March 11, 2004. Part of the corrective action included training of QC employees ... Training was not performed until May 13, 2004 on a similar product."

Next, the procedures addressing verification or validation of CAPAs were not established. For example, the report noted, CAPA procedures did not include procedures regarding the verification or validation of a corrective action. No verification was performed for the new hand operated crimping tool that was implemented into production as part of the corrective action for CAPA 2004-013.

In addition, the report noted that records of complaint investigations did not include the results of the investigation. "Specifically, the results of the investigation of complaint 2005-008 does not include either any information obtained from any direct contact with the user, such as, the method of application, or any evaluation or analysis performed by the electrode plating vendor."

The company responded that its normal complaint resolution system provided for contact with the end-user of devices acquired through dealers, distributors or OEM to be conducted through those third-party distributors. "However," the firm noted, "we will seek permission from third-party sellers for direct contact in the case of complaints."

The 483 next stated that "not all data from quality data sources are analyzed to identify existing and potential causes of nonconforming product and other quality problems."

The company noted in its response that "the investigator gave no indication that his findings were serious enough to result in more than a standard 483. I was very surprised to return from a trip out of town to receive a warning letter."

The company could not be reached for an update.

The Electrode Store, Buckley, WA, 10/3-6/05, Doc. 109919M, $5.50 plus retrieval.