CDMO Regulatory Standing and Inspection History Check

Document type	Checklist
Topic area	CDMO Governance
Level	Intermediate
Updated	September 2026

This is a ready-to-use checklist for independently confirming a CDMO’s inspection history, rather than relying on the CDMO’s own account, before a technical assessment closes. Replace every <<FILL: ...>> placeholder with your own specifics and route it through your normal document control, review, and approval. A worked filled specimen follows. Verify each cited reference against the current source before you rely on it.

Document control header

Field	Entry
Document title	Regulatory Standing and Inspection History Check for `<<FILL: CDMO / site>>`
Document number	`<<FILL: e.g. CDMO-RH-2026-01>>`
Version	`<<FILL>>`
Effective date	`<<FILL>>`
Site(s) checked	`<<FILL>>`
Checked by	`<<FILL>>`

1. Purpose

This checklist records an independent check of <<FILL: CDMO / site>>’s inspection and regulatory standing history, run from primary public sources rather than the CDMO’s own summary, and its disposition into the technical assessment findings register.

2. Scope

Dimension	Decision
Site(s) checked	`<<FILL>>`
Regulators checked	`<<FILL: e.g. FDA, EMA/EudraGMDP, other named authority>>`
Out of scope	`<<FILL: e.g. sub-tier suppliers, checked under the raw-material sourcing assessment>>`

3. Responsibilities

Role	Responsibility
Regulatory / CMC	Runs this check, interprets findings, routes anything material to QA.
Quality Assurance	Reviews findings, approves the disposition, owns any documented risk acceptance.

4. FDA check

Item	Pass / Fail / N/A	Notes
Searched FDA’s Inspection Classification Database by firm name, trying known name variants (prior names, parent company, acquisitions)	`<<FILL>>`	`<<FILL>>`
Cross-checked against the weekly Data Dashboard inspections update for anything not yet in the classification database	`<<FILL>>`	`<<FILL>>`
Confirmed the project area(s) returned match the actual process/product type relevant to this program, not just an overall site impression	`<<FILL>>`	`<<FILL>>`
Checked FDA’s warning letter database for the firm name and known variants	`<<FILL>>`	`<<FILL>>`
Checked for an active import alert against the firm	`<<FILL>>`	`<<FILL>>`

5. EU / other regulator check (if applicable)

Item	Pass / Fail / N/A	Notes
Searched EudraGMDP for manufacturing/import authorizations, GMP certificates, and statements of non-compliance	`<<FILL>>`	`<<FILL>>`
Checked whether the site holds standing with more than one regulator, and searched each	`<<FILL>>`	`<<FILL>>`

6. Classification reference

Classification	Meaning	Typical action
No Action Indicated (NAI)	No objectionable conditions found in the inspected project area	Confirm the project area matches your process; no further action required
Voluntary Action Indicated (VAI)	Objectionable conditions found, not on their own warranting further regulatory action	Request the CDMO’s CAPA response and closure evidence; assess relevance to your unit operation
Official Action Indicated (OAI)	Objectionable conditions found warranting further regulatory action	Route to Regulatory/CMC and QA for a documented risk position before proceeding

7. Findings and disposition

Finding	Classification / source	Relevant to this program?	Disposition	Owner	Target date
`<<FILL>>`	`<<FILL>>`	`<<FILL: Yes/No>>`	`<<FILL>>`	`<<FILL>>`	`<<FILL>>`

8. Conclusion

<<FILL: state plainly whether the check surfaced anything material, and whether the assessment can proceed, proceed with a documented risk acceptance, or should not proceed pending remediation>>

9. References

FDA Inspection Classification Database and Data Dashboard. EudraGMDP, the EMA’s public database of manufacturing/import authorizations, GMP certificates, and non-compliance statements.

Confirm the current version and URL of each source before issue.

10. Revision history

Version	Date	Author	Summary of change
`<<FILL: 1.0>>`	`<<FILL>>`	`<<FILL>>`	Initial issue.

11. Approvals

Role	Name	Signature	Date
Author (Regulatory / CMC)	`<<FILL>>`
Approver (QA)	`<<FILL>>`

Filled specimen

Extract for an example fill-finish CDMO check. Company and specifics are illustrative.

Item	Pass / Fail / N/A	Notes
FDA Inspection Classification Database search	Pass	Site’s current legal name and one prior name (pre-2024 acquisition) both searched; both returned
Project-area check	Pass, with a note	Fill-finish project area shows NAI at the most recent inspection; a separate warehousing/distribution project area at the same site shows a VAI from an earlier inspection, unrelated to the manufacturing suite in scope
Warning letter database	Pass	No warning letter found under either name variant
Import alert check	Pass	No active import alert found

Finding: the VAI on the warehousing/distribution project area does not touch the fill-finish suite or process in scope for this program. Disposition: no action required for this program; noted in the findings register for awareness, not treated as a blocking finding. Conclusion: check surfaced nothing material to this program; the assessment proceeds.

Common inspection findings this checklist prevents

A technical assessment that closes having relied entirely on the CDMO’s own inspection-history summary.
A single-name search that misses history filed under a prior name, parent company, or acquired entity.
An overall “clean” impression drawn from one project area’s classification without confirming it is the relevant one.
A finding identified but never given a disposition, owner, or date in the assessment record.

How to adapt this checklist

Set your document number and the CDMO/site being checked in the header.
Search every plausible firm name variant in section 4, not just the current legal name.
Confirm the project area matches your actual process before treating a classification as reassuring.
Route anything material through section 7 with a named owner and date, and write a plain conclusion in section 8.