FDA Inspection Notice Response Service
Timely Response Support Aligned with the U.S. Code of Federal Regulations and FDA Regulatory Expectations
An expedited-response service for food facilities, importers, and brand owners who have received an FDA inspection notice or post-inspection communication requiring an urgent written response. This service ensures your facility is represented professionally, with a complete and compliant response that demonstrates readiness, accountability, and regulatory alignment.
Ideal For
- • Food facilities under scheduled or surprise FDA inspections
- •Companies (foreign or local) receiving Form 482 or FDA inspection-related correspondences
- •Importers managing FDA scrutiny under FSVP or supplier-related gaps
- •Facilities needing professional support to avoid escalation or warning letters
Scope of Services
- • Collect and assess information and records requested by the FDA, which may include but not limited to:
- ∘ Facility information
- ∘ Organizational structure
- ∘ Process overview and/or SOPs
- ∘ FDA registration information
- ∘ Point-of-contact information
- • Conduct a strategic review of FDA notice (US FDA Inspection Notification Letter, Form 482, or equivalent)
- • Coordinate call and response planning
- • Draft an FDA-ready response letter for client review and signature
- • Provide guidance in filling out requested documentation from the FDA (e.g., Factory Profile, Demand for Records, Request for Information), if applicable
- • Support in organizing requested documentation for submission (e.g., FDA registration, SOPs, factory profile, facility and point-of-contact information)
- • Facilitate guidance in submission on behalf of the client
- • Provide support for responding to immediate follow-ups during the response period
Deliverables
- • FDA Response Letter (editable draft)
- • Submission instructions or coordination Support
Pricing and Timeline
Standard: $2,500.00 (up to 5 days)
Expedited: $3,000.00 (up to 48 hours)
Add‑on Services
- • Remote Pre-FDA Inspection Compliance Gap Assessment – $4,750 per facility
- • On-site Pre-FDA Inspection Compliance Gap Assessment – $4,900 + miscellaneous
- • HACCP/Food Safety Plan Development – $2,200.00 per product (Includes full HACCP plan, hazard analysis, CCPs, and validation)
- • On-site Support Visit (w/ in-person implementation coaching) – $1,200.00/day + miscellaneous
- • Dietary Supplement GMP Compliance SOP Templates – $2,950.00
- • Human Food cGMP & HARPC Compliance SOP Templates – $2,950.00
Act now to avoid escalation.
When the FDA issues a notice requiring a response, time is critical.
Secure your response support today and let us help you manage the process with confidence.