What to tell your vendors during an FDA inspection

A supplier or contract laboratory can become an important source of records during an inspection. Prepare the communication pathway before an urgent request arrives.

Know who owns each record

Map where relevant records reside, who can retrieve them, and who is qualified to explain the work. For drug contract manufacturing, FDA’s quality-agreement guidance discusses delineating manufacturing activities and responsibilities. Use the applicable agreement and requirements for the actual relationship.

Make a precise request

Identify the product or material, lot or work order, record period, method or configuration where relevant, and the question being addressed. Explain authorized handling and access arrangements. Do not ask a vendor to backdate, reconstruct missing evidence from guesses, or alter a record to fit a preferred explanation.

Keep facts and hypotheses apart

If the vendor identifies an issue, obtain the original evidence and the scope of what is known. Avoid turning an informal explanation into a confirmed root cause. Document who reviewed the information and how it affects the company’s next decision.

Use a coordinated response

Designate contacts for retrieval, technical review, and communication. Follow applicable obligations and authorized information-sharing arrangements. Seek appropriate advice when the scope or confidentiality of a request is unclear; this article is not guidance to delay or obstruct a lawful inspection.

Supplier qualification support and contract laboratory learning can help prepare these handoffs.

Source context, reviewed October 20, 2026: Official FDA or eCFR reference. The working methods and discussion prompts in this article are independent preparation suggestions, not an official agency checklist or a complete statement of applicable obligations.

Related decisions and learning

Buying a regulated business · Briefing your board · Investor communication · Fractional QA · Short guides · Proposed training