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.

Schedule Discussion with John F. Murray, Jr.

John is currently providing telephone and face-to-face meetings to discuss:  Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.

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