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.
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 summary file ID: fa3a28c29c474b7c8a4e3583229d6d97
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