FDA inspections and enforcement · Training guide
FDA Inspection Readiness
Prepare a site for an FDA inspection and write the mock inspection report: every inspection system reviewed, findings written as FDA observations, repeat-observation risk, data integrity and the pre-approval objectives checked.
Open the tool at https://app.cmcfy.com/app/inspection-readiness.html. This guide is also online at https://cmcfy.com/guides/inspection-readiness.html
1. What this module does
You choose the programme and the inspection type, list the systems your mock investigators reviewed, write each finding the way an FDA investigator writes a Form 483 observation, and list the observations from the last FDA inspection with the status of their CAPA.
The tool works out readiness for each system (CP 7356.002 for drugs, biologics and APIs; the QMSR areas for devices), flags systems not reviewed, open critical and major findings, findings that repeat an earlier FDA observation, earlier CAPAs that are open or not verified effective, data integrity gaps and slow records production. For a pre-approval inspection it checks the three PAI objectives of CP 7346.832.
What you get
- A Word or PDF file: mock FDA inspection report with readiness by system, observations, earlier FDA observations, logistics and the conclusion.
2. Before you start
Have these ready. You can still start with the example data and replace it piece by piece.
- The mock inspection notes for each system.
- The last Form 483 and your response.
- CAPA and effectiveness records for the earlier observations.
3. Step by step with the example
Open the tool at app.cmcfy.com/app/inspection-readiness.html. The example is loaded when the page opens, so every panel already has realistic data. Follow the steps to see how it works, then replace the example with your own data.
Describe the site and inspection
Give the site, FEI number, programme and inspection type. For a pre-approval inspection, name the application.
List the systems and findings
One row per system reviewed, then one row per finding with the system, the observation, the 21 CFR section, its class and the CAPA.
Add the earlier FDA observations
One row per observation from the last Form 483, with whether the CAPA is closed and its effectiveness verified.
Read the result
The headline gives the outcome, for example "Not ready: 1 critical issue" or "Ready with 4 gaps to close".
Readiness by system and the mock findings. Resolve alerts and download
Open critical findings, findings that repeat an earlier FDA observation and unconfirmed PAI objectives are critical. Systems not reviewed, open major findings, earlier CAPAs not verified and data integrity gaps are flagged. Then preview and download.
4. Field reference
Every input in the tool, panel by panel. Tables accept rows pasted straight from Excel, comma-separated text, or a loaded file; check the columns after loading a file. Fields marked “when it applies” appear only for the choices that need them.
1 · Site and inspection
| Field | What to enter |
|---|---|
| Site | Type it in. |
| FEI number | Type it in. |
| Programme | Choose one: Human drugs: 21 CFR 210 and 211; APIs: ICH Q7, FD&C Act 501(a)(2)(B); Biologics: 21 CFR 600–680 and 211; Medical devices: 21 CFR 820 (QMSR). |
| Inspection type | Choose one: Surveillance (routine); Pre-approval or pre-licence (CP 7346.832); For-cause; Follow-up after a 483 or warning letter. |
| Application under review when it applies | Type it in. |
| Mock inspection report number | Type it in. |
| Mock inspection date | Type it in. |
| Last FDA inspection and outcome | Type it in. |
| Hours to produce a standard records request in the mock | Type a number. |
2 · Systems reviewed
One row per system reviewed in the mock inspection. Drugs: quality system, facilities and equipment, materials, production, packaging and labeling, laboratory control.
| Field | What to enter |
|---|---|
| Systems | A table. Columns: System | Date reviewed | Mock investigator (independent of the area) | Records sampled. Paste rows from Excel, type comma-separated rows, or press Load file (Excel, CSV, Word, PDF or a scan). |
3 · Mock inspection findings
Write each finding as an FDA observation: what was seen, with the record and date. Class: critical, major or minor.
| Field | What to enter |
|---|---|
| Findings | Write the observation as the investigator would: what was seen, in which record, how many of how many sampled. A table. Columns: ID | System | Observation | 21 CFR | Class (critical/major/minor) | CAPA | Owner | Due | Status (open/closed). Paste rows from Excel, type comma-separated rows, or press Load file (Excel, CSV, Word, PDF or a scan). |
4 · Earlier FDA observations
| Field | What to enter |
|---|---|
| Earlier Form 483 observations | Effectiveness verified means you have data that the CAPA worked, not only that it was done. A table. Columns: Observation | Year | Observation text | CAPA status (open/closed) | Effectiveness verified (yes/no). Paste rows from Excel, type comma-separated rows, or press Load file (Excel, CSV, Word, PDF or a scan). |
5 · Inspection logistics
| Field | What to enter |
|---|---|
| Inspection management SOP current; host, scribes and runners trained | Tick the box if it applies. |
| Front room and back room set up, with a request log | Tick the box if it applies. |
| Subject matter experts named and rehearsed for each system | Tick the box if it applies. |
| Data integrity walk-through done (audit trails, user access, shared logins, deleted data) | Tick the box if it applies. |
| Storyboards ready for open deviations, OOS results, complaints and recalls | Tick the box if it applies. |
| Process for records requests under FD&C Act 704(a)(4) and remote regulatory assessments | Tick the box if it applies. |
| PAI objective 1: ready for commercial manufacturing when it applies | Tick the box if it applies. |
| PAI objective 2: conformance to the application (process, methods, specifications) when it applies | Tick the box if it applies. |
| PAI objective 3: data in the application traced to raw data when it applies | Tick the box if it applies. |
5. Checks and alerts
Calculations and pass/fail outcomes always come from fixed rules, never from AI. The tool checks:
- Every inspection system reviewed.
- Open findings and repeat-observation risk.
- Data integrity, records requests and the PAI objectives.
How to resolve alerts
- Critical alerts block the download and must be fixed in the data. A failing result can instead be linked to an investigation: type the investigation reference and outcome and press Record.
- Major alerts block the download until you fix them or type a justification and press Accept justification.
- Minor alerts do not block anything. They are listed in the documents so the reviewer sees them.
- Some alerts have an Apply fix button that makes the change for you. Reopen undoes a justification.
Narratives
This module writes: Summary and conclusion. Each narrative is written by fixed rules from your data. You can edit it in the box. Rewrite with AI (where your plan includes AI) rewrites it in regulatory style; every number in the text is checked against your data, and a number that does not match is flagged under the box and blocks the download until you correct it. Reset to rule-based text brings back the original.
6. Preview, gap review and download
- Press Preview next to a section, or Preview and download all. The document opens in a preview window, exactly as the Word file will read.
- The left side lists the review, run on your device: gaps in the data (missing values, open alerts), gaps in the report (missing content the guidance expects, placeholders such as [site] or TBD left in the text) and, if you load the approved protocol under Compare with the protocol, differences from the protocol (requirements, criteria, batches or time points it plans that the report does not show).
- Click a finding to jump to the place in the preview. Fix it in the tool, then preview again.
- Optional AI review: a second read for contradictions, claims without data and vague wording. The report text is sent to Claude only when you press it, and only where your plan includes AI. Check every AI finding; AI can be wrong.
- Press Download Word (.docx) or Download PDF. With several documents open, All as Word (.zip) and All as PDF (.zip) download the set. The download buttons stay disabled while a blocking alert is open; the preview still works.
Documents this module produces
| Section | Document |
|---|---|
| Report | Mock FDA inspection report |
Use Save project to keep your work as a file on your computer, and Open project to continue later. Start blank clears every field; Load example brings the example back. Nothing is stored on CMCfy servers.
7. US and EU submissions
US only: FDA inspections under FD&C Act 704. For EU GMP inspections, use the Self-Inspection Report report with EU GMP Chapter 9.
8. Working with other modules
- Answer a real Form 483 with the Form 483 Response, and check what FDA cites most with FDA Citation Trends.
9. Common pitfalls
- Mock findings written as opinions rather than as evidence an investigator would record.
- Earlier 483 CAPAs closed on paper but never checked for effectiveness.
10. Practice exercises
Each exercise starts from the example (press Load example to reset). We run these on every update of this guide, so the result you see should match.
Confirm the third PAI objective
Tick "PAI objective 3: data in the application traced to raw data".
Expected resultNo critical issue remains; the open major gaps are listed.
Repeat an earlier FDA observation
Change finding MI-04 to "Cleaning validation did not include the worst-case product for granulator G-2".
Expected resultThe repeat of 483-2 is critical.