FDA Inspection Observation Summary for 2015.

FDA issued “2015 Annual FDA Medical Device Quality System Data Inspections, FDA Form 483 Observations, and Warning Letter Citations”. The full report is at the link provided.

This report identifies numbers of observations and inspections by country as well as obervations by Quality subsystem. FDA noted that the number of Foreign inspection has increased. Production and Process Controls and CAPA continue to be the most frequently cited.

The most frequent Design Control citiations were Design Validation by a large margin then Design Changes followed by Design Verification with a much lower number related to other elements of Design Control.

Software Verification

Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification?  We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing.  Call us at 781-721-2921 or email office@softwarecpr.com to start a conversation.  We can provide estimates of cost and support your development tools.

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