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Static demo · Fictional supplier and records. This example does not contain live FDA data.

Sample supplier review

Example Supplier A

Illustrative drug manufacturing site · Example as of June 1, 2025

Review your supplier

What changed in this example

The latest example inspection is classified VAI; the previous example inspection was classified NAI. Review the underlying observation and the supplier’s response before deciding your next action.

Previous · March 8, 2023

NAI

No Action Indicated

D3 · Example inspection

Latest · May 12, 2025

VAI

Voluntary Action Indicated

D1 · Example inspection

The example observation concerns an investigation that did not document whether other batches were affected. Read the supporting excerpt (D2).

This comparison describes two example records. It does not establish a trend, verify remediation, or assign a supplier approval decision.

Inspect the evidence

Open each source to see what supports the finding and what remains unknown. These are local teaching fixtures, not FDA documents.

D1Inspection recordMay 12, 2025 · Fictional

Illustrative FDA inspection fields

Inspection end date: 2025-05-12. Classification: VAI. Product type: Drugs.
Supports
The latest inspection in this example is classified VAI.
Limitation
Classification alone does not explain the observation or establish current compliance.

Source: FDAgent static demo fixture D1. No live record identifier or retrieval is represented.

D2Observation excerptMay 12, 2025 · Fictional

Illustrative Form 483 text

The investigation record did not document an assessment of other potentially affected batches.
Supports
The example observation concerns the scope of a batch investigation.
Limitation
This invented excerpt illustrates evidence review. It is not a quotation from an FDA document.

Source: FDAgent static demo fixture D2. No live record identifier or retrieval is represented.

D3Previous inspection recordMarch 8, 2023 · Fictional

Illustrative FDA inspection fields

Inspection end date: 2023-03-08. Classification: NAI. Product type: Drugs.
Supports
The previous inspection in this example is classified NAI.
Limitation
Two inspections are not enough to establish a trend or predict a future inspection outcome.

Source: FDAgent static demo fixture D3. No live record identifier or retrieval is represented.

From finding to follow-up

What would you ask the supplier?

“Please provide the investigation’s assessment of other potentially affected batches, the rationale for its scope, and evidence that the corrective action was checked for effectiveness.”

Illustrative reviewer question based on D2. This is a suggested follow-up, not a source quotation or an FDA requirement determination.

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