Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection
This guidance defines the types of behaviors (actions, inactions, and circumstances) that FDA considers to constitute delaying, denying, limiting inspection, or refusing to permit entry or inspection for drug and device facilities subject to inspection under section 704 of the FD&C Act. The guidance aims to clarify what constitutes adulteration under section 501(j) of the FD&C Act.
Recommended Actions
- Establish clear procedures for managing FDA inspections including:
- Process for responding to inspection scheduling requests
- Protocols for escorting FDA investigators
- Procedures for providing requested records
- Guidelines for photography in facility
- Sample collection procedures
- Maintain updated facility registration and contact information
- Train staff on:
- FDA inspection rights and authorities
- Proper communication with FDA investigators
- Record access and copying procedures
- Photography policies
- Sample collection protocols
- Document reasonable explanations for any delays or limitations, including:
- Safety requirements
- Manufacturing schedule constraints
- Record compilation time needs
- Translation requirements
- Establish clear record management system to:
- Quickly retrieve requested documents
- Provide electronic records in required format
- Track record requests and responses
- Manage appropriate redactions
- Create contingency plans for:
- Staff absences during inspections
- Access to off-site records
- Translation of documents
- Large volume record requests
Key Considerations
Labelling
- Must allow FDA to inspect and collect labeling samples
Safety
- Must allow FDA investigators access to areas after following appropriate safety and gowning procedures
- Must provide required safety training if needed to access certain areas
- Must accommodate facility’s documented precautionary measures to prevent contamination
Other considerations
- Must allow FDA investigators to take photographs unless there is a reasonable explanation why it would affect product quality
- Must provide access to and copies of required records without unreasonable redaction
- Must allow collection of environmental, finished product, raw material, and in-process samples
- Must respond to FDA’s attempts to schedule pre-announced inspections
- Must not unreasonably delay or limit inspections
- Must allow access to manufacturing processes and facility areas
- Must provide records requested under section 704(a)(4) or 704(e) in a timely manner
- Must maintain valid registration information and point of contact details
Relevant Guidances
- Uniform Inspection Process and Communications for Medical Device Establishments
- Requesting Nonbinding Feedback on Form FDA 483 Inspectional Observations
Related references and norms
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Original guidance
- Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection
- HTML / PDF
- Issue date: 2024-06-20
- Last changed date: 2024-11-05
- Status: FINAL
- Official FDA topics: Medical Devices, Postmarket, Investigation & Enforcement, Drugs, Animal & Veterinary, Biologics
- ReguVirta summary file ID: c8ee0d174c2f193936a71c70e811d19c
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