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.

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

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