Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection

What You Need to Know? 👇

What constitutes delaying an FDA inspection under section 501(j)?

Delaying includes unreasonably postponing pre-announced inspections without valid explanations, leaving investigators waiting without access to documentation or personnel, or failing to produce requested records within reasonable timeframes. Manufacturing schedules or safety requirements may provide reasonable explanations.

Can FDA conduct unannounced inspections of medical device facilities?

For device facilities, FDA must pre-announce most inspections under section 704(h), except for-cause inspections. Drug facilities typically receive unannounced inspections, though pre-approval and foreign facility inspections are usually pre-announced to ensure personnel and records availability.

What records must device facilities provide during FDA inspections?

Device facilities must permit inspection and copying of records required under sections 519 or 520(g), including quality system records, complaint files, and MDR documentation. Electronic records must be provided in searchable format without unreasonable redactions or data omissions.

How does limiting FDA photography during inspections affect compliance?

Preventing FDA photography may constitute limiting inspection if photographs are necessary for documenting facility conditions, contamination, equipment issues, or labeling. Reasonable exceptions include situations where photography could adversely affect product quality due to chemical properties.

What happens if a facility refuses FDA sample collection?

Preventing FDA from collecting authorized samples (environmental, finished product, raw materials, in-process materials, or labeling samples) may be considered limiting inspection under section 501(j), potentially causing products to be deemed adulterated.

Are there reasonable explanations for restricting FDA access to manufacturing areas?

Yes, reasonable restrictions include requiring investigators to follow documented gowning procedures for aseptic areas, completing OSHA-required safety training, or preventing contamination in environmentally controlled spaces. These must be documented safety or quality requirements.

---

What You Need to Do 👇

Recommended Actions

1. 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
2. Maintain updated facility registration and contact information
3. Train staff on:
   • FDA inspection rights and authorities
   • Proper communication with FDA investigators
   • Record access and copying procedures
   • Photography policies
   • Sample collection protocols
4. Document reasonable explanations for any delays or limitations, including:
   • Safety requirements
   • Manufacturing schedule constraints
   • Record compilation time needs
   • Translation requirements
5. Establish clear record management system to:
   • Quickly retrieve requested documents
   • Provide electronic records in required format
   • Track record requests and responses
   • Manage appropriate redactions
6. 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 📂

NO_SPECIFIC_REFERENCES_MENTIONED

---

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 ID: c8ee0d174c2f193936a71c70e811d19c