Failure to adequately establish and maintain acceptance procedures, where appropriate, to ensure that specified requirements for in-process product are met as required by 21 CFR 820.80(c). 

For example: Your firm’s Veress Needle Quality Inspection Standard (Doc No. (b)(4), Ver. (b)(4), dated (b)(4)) is not adequately established, as the quality control personnel were conducting in-process acceptance activities that did not include connection bond testing, and puncture testing of the subject device. Your firm has not established and maintained in-process acceptance activity procedures to ensure specified requirements for in-process products are met. The quality personnel were conducting acceptance activities based on the Inspection Standard used to conduct in-process acceptance activities for the Veress Needles. However, according to the investigator, your firm’s quality staff conducting the in-process acceptance activities were not familiar with the testing process and stated there were no established in-process acceptance procedures for the connection bond and puncture testing. However, in the Semi-Finished Inspection Record ((b)(4)), there is a requirement included to conduct a connection bond test and puncture test, that the quality staff conducting the in-process acceptance activities were not familiar with. The requirement listed in the semi-finished inspection record was not included in the final Veress Needle Quality Inspection Standard. 

We have reviewed your firm’s response in the 483 Corrective Action Plan dated October 8, 2021, and have concluded it is not adequate. You plan to modify the Veress Needle Quality Inspection Standard and all other quality inspection standards, train relevant personnel of the quality and production department according to the revised Quality Inspection Standards, and perform retrospective review for all products which had been sold for the U.S market, to analyze if there is any quality issue or adverse event occurred. These actions have not been completed. In addition, your firm has not identified plans to evaluate their document control system, to make changes to ensure the requirements are consistent across documents. To ensure conformance to the standard across all relevant in-process acceptance activities, you should evaluate your document control system as part of your corrective action plan.