Form FDA 483 Response Team
Respond fast. Stay organized. Show evidence.
FDA encourages firms to respond in writing with corrective action plans and supporting documentation within 15 business days from issuance of the Form FDA 483.
- Response letter + CAPA plan
- Evidence package
- Executive commitment & timeline
Request Response Support
We’ll match you with remediation experts to help assemble your response package.
What is Form FDA 483 (and what it is not)
Form FDA 483 (Inspectional Observations) is a list of observations made by FDA investigators during an inspection. It documents conditions that may violate the Food, Drug, and Cosmetic Act and related regulations. It is not a final determination of violation; it is a notice of what the investigator observed. The firm may respond in writing to address each observation.
The 15-business-day response window & why speed matters
FDA encourages firms to respond in writing with corrective action plans and supporting documentation within 15 business days from issuance of the Form FDA 483. Responding promptly shows commitment to compliance and helps move toward inspection close-out. Delays can affect follow-up (e.g. Warning Letter, enforcement) and business operations.
The "Response Package" we help you assemble
Deliverables checklist: cover letter with management sign-off, response letter addressing each observation with root cause and CAPA, evidence index and supporting documents (revised SOPs, training records, validation reports, CAPA logs), timeline table, and effectiveness check plan.
Common observation areas
QMS topics often cited: CAPA, design controls, production and process controls, purchasing/supplier controls, validation (process, software, cleaning), labeling, complaint handling, MDR/vigilance, documentation (DHF, DMR, DHR), management responsibility, training, and cybersecurity where applicable.
How matching works
- You submit the form above. We triage within 1 business day.
- We match you with 1–3 vetted QA/RA remediation providers (and optionally counsel) based on product type, systems impacted, observation count, and respond-by date.
- You work with them directly to assemble your response. We are a marketplace; we do not provide legal or regulatory advice.
Documents checklist
- Form 483 (copy)
- Org chart / quality structure
- Relevant SOPs
- Records (training, calibration, batch records as applicable)
- CAPA logs
- Complaint files
- Validation evidence (process, software, cleaning)
Frequently asked questions
What is a Form FDA 483?
A Form FDA 483 lists inspectional observations presented to management at the close of an inspection. It is not a final agency determination.
Do I have to respond to a Form 483?
A response is generally voluntary, but FDA encourages a written response with corrective action plans and supporting documentation.
How long do I have to respond?
FDA encourages responses within 15 business days from issuance (with supporting documentation as available).
What should a strong 483 response include?
For each observation: acknowledgement, root cause summary, CAPA plan, objective evidence, timelines, and how you'll verify effectiveness.
Do I need evidence in the initial response?
Provide what you have (e.g., revised procedures, training records, containment actions). If work is in progress, include a credible timeline and milestones.
Should senior leadership sign the response?
Often yes—leadership commitment helps demonstrate accountability and resourcing (without overpromising).
What if an observation is inaccurate or missing context?
Address it respectfully with facts, supporting documents, and a clear explanation; avoid a defensive tone.
How quickly can you start?
We can intake immediately and match you to providers based on product type, systems impacted, and urgency.
This page is for informational purposes only and does not constitute legal advice. Cruxi is a marketplace/matching service; we are not FDA and are not a law firm. We do not guarantee outcomes. We match you with vetted providers who may assist with 483 response and remediation. See our Privacy Policy for how we share data with matched providers.