Pre-approval inspections, routine inspections, compliance follow-up inspections, and “for cause” inspections are the four types of FDA inspections. Each is meant to safeguard the public from dangerous items, but the focus and expectations of each vary. For more information, you can Go now.
- Pre-Approval Inspections
Pre-Approval After a company applies to the FDA to commercialize a new product; inspections are done. These inspections are focused on validating the information provided in the application and ensuring that the facility can produce the product in question.
- Routine Inspections
Manufacturers of class II and class III devices must conduct routine inspections every two years. They adhere to a set of guidelines known as the Quality System Inspection Technique (QSIT), which will be covered further down in this article. If a significant public health concern is discovered during a routine inspection, it may be converted to a “for cause” inspection.
- Compliance Follow-Up Inspections
Follow-up on Compliance Inspections looks at what a company or manufacturer did after a previous inspection that resulted in 483 observations or a Warning Letter. A compliance follow-up is undertaken to ensure that earlier infractions have been adequately corrected, ongoing document violations, or support future regulatory action.
- “For Cause” Inspections
“For a Reason” Inspections look into a specific issue that has been brought to FDA’s attention. The manufacturer (e.g., as a result of a recall, MDR), consumer/user complaints, or even a disgruntled staff could be the source of the report.
A “for cause” inspection will focus on the specific issue at hand, but it may also include irrelevant aspects of its operations. This inspection is frequently requested by the CDRH, ORA, or a regional directive. These inspections are usually more thorough than routine inspections, and they may or may not follow the QSIT methodology.
What is preparing for inspections?
Will you be notified when the FDA arrives? It is debatable. Pre-approval and routine inspections are usually announced five days ahead of time. Firms with a history of violative inspections will not be given this privilege, and FDA inspectors may arrive without warning. Inspections for compliance follow-up and “for cause” are not disclosed ahead of time. An FDA inspection of a foreign establishment is usually scheduled two to three months ahead of time to allow travel and logistics.
Management Controls, Design Controls, Corrective and Preventive Actions (CAPA), and Production and Process Controls are the four primary subsystems of the quality system identified by QSIT. It assesses and describes each subsystem’s purpose and importance and gives flowcharts and inspectional objectives for each subsystem.
It is your responsibility to always be prepared for FDA inspections, regardless of the type of inspection. The first step is to understand the different inspections and prospective inspection locations. Make sure you meet down with your team and develop a realistic inspection readiness plan. Have a protocol in place so that when an FDA inspector visits your business, your personnel know what to do and how to act. Finally, it’s always a good idea to keep your quality system documentation current and accessible.