Recipient: Vapotherm Inc
Product:”Vapotherm 20001″ respiratory gas humidifier
Date: 6/12/06
Failure to verify and validate corrective and preventive actions to ensure that the action is effective and does not adversely affect the finished device, as required by 21 CFR 820.100(a)(4). For example, CAPA 05-032 includes a request to review cleaning protocols for improvement in existing cleaning methods for the cartridge. This resulted in a change in the recommended cleaning methods from Control III to MB-10 tablets (chlorine dioxide) and Minntech method (peroxyaceitic acid). The new cleaning methods were approved via Engineering Change Order (ECO) _____ on _____ and released for distribution on 10/19/05. The use of the MB-10 tablets has not been validated for use on the Vapotherm 2000i. The Minncare method, while having clearance to clean the cartridge (via 510(k) K041984), has not been validated to clean the cartridge while attached to the Vapotherm 2000i. from quarantine. The CAPA for this instance was initiated on January 27, 2005.
Failure to establish and maintain complaint handling procedures for receiving, reviewing, and evaluating complaints, as required by 21 CFR 820.198(a). For example:
The off-the-shelf, web-based commercial software program, ” _____”, is used by your firm to collect, track and trend data and to supply reports of complaints, sales and repairs data. Your firm does not have a procedure that describes how to use the “_____” program. You also indicate that you intend to use the _____ software in the future. At the time that you reintroduce the software as your method for complaint handling, you will need to maintain complaint handling procedures that describe how the software is to be used.
Failure to validate software, used as part of the quality system, for its intended use according to an established protocol, as required by 21 CFR 820.70(i). For example, the off-the-shelf, web-based, commercial program _____ is used by your firm to collect, track, and trend data, and to supply reports of complaints, sales and repairs data. Your firm has not validated the “_____” program.
Your response dated 01/20/06 appears adequate. You stated that you are discontinuing the use of the software until it has been validated. Once you have validated the software for its intended use, you will need to maintain an established protocol for the validation of the software and keep record of the validation that was performed. This will be verified at the next inspection of your facility.
FDA District: Baltimore District Office
