Lack of Adequate CAPA Procedures Tops FDA’s List of Violations
FDA’s Office of Regulatory Affairs has released the most frequently cited inspectional observations for fiscal year 2017. Lack of or inadequate procedures related to DHRs, calibration and inspection, process control, quality audits and design changes were high up on the list.
“These observations, are listed on an FDA Form 483 when, in an investigator’s judgment, the observed conditions or practices indicate that an FDA-regulated product may be in violation of FDA’s requirements.” – FDA
The following are the observations that exceeded 100 in frequency:
- CAPA activities or results not adequately documented: 115
- Nonconforming product; procedures not adequately established: 127
- Lack of written MDR procedures: 127
- Lack of or inadequate process validation: 137
- Lack of or inadequate procedures involving purchasing controls: 138
- Lack of or inadequate complaint procedures: 269
- Lack of inadequate CAPA procedures: 400
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