Reinspection of Firms During Pending Legal Actions
This guidance clarifies FDA's policy regarding the reinspection of firms while legal action is pending against them. It addresses when and why reinspections should be conducted during ongoing legal proceedings.
What You Need to Know? 👇
Should FDA inspections continue for medical device companies while legal action is pending?
Yes, FDA should continue inspections based on public health considerations. The agency has an obligation to determine compliance regardless of pending legal cases, and cessation of violations doesn’t dismiss existing cases.
What determines whether to reinspect a medical device facility during litigation?
Reinspection decisions should be based on public health considerations, available resources, and priorities. Court requests also warrant reinspection to provide current information about the defendant’s operations.
Can FDA take additional enforcement action if new violations are found during reinspection?
Yes, if reinspection reveals further violations, FDA can take additional enforcement steps as necessary to ensure correction, even while other legal action is pending against the firm.
Does correcting violations after an FDA inspection dismiss pending prosecution cases?
No, prosecution actions are based on violations that already occurred. Nothing that happens after the violation, including correction of the issue, changes the basis for the legal case.
When should FDA inspect a medical device company before court proceedings?
FDA should not routinely inspect firms just before arraignment or trial unless specifically requested by the court or justified by public health considerations and available resources.
What information should FDA districts maintain during pending legal cases?
Districts should be prepared to furnish courts with current information about defendant operations when requested, ensuring they can provide up-to-date compliance status during legal proceedings.
What You Need to Do 👇
Recommended Actions
- Establish a process to evaluate the need for reinspection based on public health considerations
- Maintain documentation of all violations, even if they have been corrected
- Create a procedure to respond to court requests for reinspection
- Develop a system to maintain current information about operations for court proceedings
- Implement a risk-based approach to determine reinspection priorities
- Ensure proper documentation of reinspection findings that may support ongoing legal proceedings
- Train inspection staff on the proper handling of inspections during pending legal actions
Key Considerations
Other considerations
- Reinspections should be based on public health considerations
- FDA maintains the obligation to determine compliance even during pending legal actions
- Cessation of a violation is not grounds for case dismissal
- Reinspections should be conducted when requested by a court
- Current information about operations should be available to courts when needed
- Routine pre-trial inspections are not required unless specifically requested by court or justified by public health concerns
Related references and norms 📂
No specific norms or standards are referenced in this guidance.
Original guidance
- Reinspection of Firms During Pending Legal Actions
- HTML
- Issue date: 1989-08-30
- Last changed date: 2018-12-01
- Status: FINAL
- Official FDA topics: Radiation-Emitting Products, Tobacco, Medical Devices, Food & Beverages, Dietary Supplements, Investigation & Enforcement, Drugs, Animal & Veterinary, Food & Color Additives, Biologics, Cosmetics
- ReguVirta ID: fa3a28c29c474b7c8a4e3583229d6d97