FDA Inspections: Focus Points for Biologics, Medical Device, & Drug Manufacturers
Are you preparing for a regulatory inspection by the Food and Drug Administration (FDA)? Our industry is built upon quality as a foundation and having a compliant or non-compliant Quality Management System (QMS), will not only impact patients’ lives, but it could shut down businesses. The FDA oversees these inspections, sometimes unannounced, and in person ready to roll!
Who is the Office of Inspections and Investigations (OII)? The OII leads all field inspection, investigation, import, emergency response, and law enforcement activities to protect the United States’ public health and safety. This department inspects FDA-regulated products such as foods, human and animal drugs, cosmetics, and medical devices. They investigate complaints, screen imports, collaborate with domestic and foreign partners, and provide emergency responses to protect the public [2]. They ensure manufacturers’ products are compliant, safe, effective, and are of the highest quality.
As seen in the charts below provided by the FDA, these areas are trends that have appeared in Warning Letters issued to manufacturers who have been found to be non-compliant.
[1]
[3]
Current Good Manufacturing Practice (CGMP) and Current Good Tissue Practice (CGTP) infraction trends showed manufacturers performed inadequate investigations and/or lacked proper risk assessments for their QMS to maintain compliance, especially when handling complaints and reported adverse events. These trends also emphasize the need for continuous improvement efforts by manufacturers to reflect their commitment to quality, especially for their patients and partnerships.
The FDA uses a risk-based approach [4] for their inspections based on several factors such as, but not limited to:
Facility type (e.g., laboratory, manufacturer, tissue recovery/acquisition, distributor, etc.)
Organization’s compliance to regulations and when the last inspection occurred and if there were any observations found
Complaint reports, hazards, recalls etc.
Why does this matter? If you missed one of our previous blogs, check out “The New Adventure of FDA and Elsa A.I.” as FDA will be using Elsa as key to identify “high priority” inspection targets.
If you or your organization have any questions on FDA regulatory inspections, contact us here!
See you next time!
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