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.

Remote Webmeeting Assessments

SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

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