Recipient: Sonotech Inc.
Product:Ultrabio Sterile ultrasound coupling gel
Failure to validate processes that cannot be fully verified by subsequent inspection and test; failure to establish and maintain procedures for finished device acceptance; failure to maintain a device master record that referred to the location of the packaging and labeling specifications; failure to conduct quality audits by individuals who do not have the responsibility for the matters being audited; failure to follow internal quality audit procedures; failure to establish and maintain procedures for validating the device that include software validation and risk analysis; failure to maintain procedures for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements; failure to establish procedures to control all documents; and failure to maintain your procedures to control product that does not conform to specified requirements.
Your firm failed to establish and maintain procedures for validating the device that include software validation and risk analysis, where appropriate, as required by 21 CFR 820.30(g). The risk analysis for the Ultrabio does not meet the requirements of procedure “Design Input Checklist & Risk Management,” document No. PD-03, Revision 04. The risk analysis fails to include the analysis of the probability of occurrence of an identified hazard, the decision on whether the estimated risks are so low that risk reduction is not needed, and is not signed by the person who conducted the risk analysis.
FDA District:Seattle District Office