tl;dr: In 2025, inspections are tougher and often unannounced. Atlas AI Copilot helps QA teams see what each inspector focuses on, their common observations, and gives a step-by-step prep guide—so teams stay ready and avoid surprises.
If you work in pharma or biologics, 2025 feels like the year inspections got real again. FDA is inspecting more, posting more 483s publicly, and pushing for stronger quality systems. At the same time, QA teams are lean and timelines are tight. That’s exactly why teams are adopting Atlas AI Copilot—to get inspector-specific intelligence, faster prep, and fewer nasty surprises.
Below is a clear, simple guide to what changed in 2025, why Atlas helps, and a step-by-step playbook to prepare for your inspector.
What Changed in 2025
FDA inspections rose sharply: Drug quality inspections increased to nearly 1,000 in the last fiscal year, the highest in recent years. More than 60% of these were outside the U.S., making global readiness more critical than ever.
More public inspection records: FDA now posts new 483s, EIRs, and related inspection documents online faster and with better search options, making it easier to spot trends.
Unannounced foreign inspections expanded: FDA confirmed that it will conduct more unannounced visits at overseas sites, following pilot programs in India and China.
Quality Management Maturity (QMM) programs grew: More companies are voluntarily joining FDA’s QMM initiative to demonstrate strong, proactive quality systems.
Enforcement is on the rise: Warning letters tied to drug quality issues hit their highest level in five years.
Focus on domestic manufacturing: FDA also announced new programs to encourage U.S.-based manufacturing, putting a spotlight on facility readiness and quality systems.
Why Teams Are Choosing Atlas AI Copilot
Atlas AI Copilot is built for inspection intelligence—across FDA and other agencies. In simple terms, it helps you:
Know your inspector before they walk in- Atlas analyzes that inspector’s history (483s, citations, past outcomes) so you see the topics they usually push on and the observations they write most.
See what’s trending now- Get current year trends (like spikes in cleaning validation or data integrity citations) without hours of manual digging.
Convert insights into action- The Copilot turns hot-spots into ready checklists, sample questions, and evidence lists for your team.
Benchmark and compare- Compare your own SOPs and processes against peer inspection outcomes and recent 483 language.
Prep your Day-1 binder in minutes- Auto-assemble the documents inspectors routinely ask for: org charts, training matrices, validation plans, CAPA logs, supplier status, utilities data, and more.
Respond smarter- Draft CAPA and response outlines modeled on recent, successful examples for similar observations.
What a specific inspector usually looks for
Every inspector has patterns. Some focus on data integrity and investigations, others on cleaning validation, aseptic technique, or supplier controls. Atlas builds an Inspector Profile showing:
Top CFR sections they cite most often (like 211.100 process controls, 211.160 lab controls, 211.192 investigations, 211.67 cleaning, and 211.25 training).
Recent 483 excerpts that show how they phrase observations.
Average number of observations and common follow-up requests (such as raw data, audit trails, or deviation trends).
Quick note on using Atlas
Open Atlas → choose USFDA Investigator in the search bar → type the investigator’s name → choose the 7th option: AI Copilot. In that Copilot view you’ll get:
What Inspectors Usually Look For
The most common observations they write
How to prepare to avoid them
Copy the “most common observations” block from Atlas and paste it into the section below if you want a perfect match.
What major areas this inspector looks at during inspections
(Short, simple — what to expect and what records they will ask for)
Process controls & validation
What they check: written procedures, change history, validation reports, in-process controls, excursions and trending.
Records to have: validation protocols/reports, change-control logs, deviation trend reports, batch records.
Laboratory controls
What they check: method validation, instrument suitability, reference standard control, sample records.
Records to have: method validation reports, calibration certificates, sample logs, lab notebooks/raw chromatograms.
Investigations (OOS / OOT)
What they check: completeness of investigations, original raw data, root cause analysis, and effectiveness checks.
Records to have: complete investigation decks, raw data files, CAPA plans and verification.
Cleaning & equipment
What they check: cleaning validation, re-validation after change, equipment maintenance, and cleaning records.
Records to have: cleaning validation reports, swab/Bioburden results, PM/calibration records.
Training & personnel
What they check: training matrices, competency checks, and observable operator technique (for sterile operations).
Records to have: training records, competency test results, media fill performance for aseptic ops.
Data integrity & computerized systems (CSV)
What they check: audit trails, electronic signatures, access control, backups, and change logs.
Records to have: audit trail extracts, user access lists, backup reports, system validation packages.
Supplier controls & supply chain
What they check: supplier qualification, incoming material testing, certificates of analysis, and audits.
Records to have: supplier master list, audit reports, CoAs, incoming testing records.
Environmental monitoring (sterile/cleanrooms)
What they check: trend data, excursions, corrective actions, and gowning behavior.
Records to have: EM trend charts, investigation reports, media fill results.
The most common observations for this inspector
(Insert Atlas Copilot output here to match the inspector exactly — below is a ready-to-use, inspector-style list you can use if you don’t paste Atlas output.)
Incomplete or superficial OOS/OOT investigations
Typical wording: “Failure to thoroughly investigate and document the cause of out-of-specification results, including raw data and meaningful root-cause analysis.”
What they expect to see: raw data, full investigation report, root cause methodology, CAPA and verification.
Data integrity gaps (missing/altered raw data or audit trails)
Typical wording: “Records do not provide a complete, attributable, and permanent raw data trail; audit trail missing or not available.”
What they expect to see: unaltered raw data, audit trail exports, login and change logs.
Process validation not complete or not followed
Typical wording: “Process validation documentation is incomplete or does not demonstrate control under routine manufacturing conditions.”
What they expect to see: complete validation reports, re-validation after changes, documented acceptance criteria.
Inadequate laboratory method validation and controls
Typical wording: “Laboratory methods are not properly validated or system suitability is not demonstrated for release testing.”
What they expect to see: method validation reports, system suitability records, calibration logs.
Cleaning validation or sanitation program weaknesses
Typical wording: “Cleaning validation studies are absent, incomplete, or the acceptance criteria are not defined.”
What they expect to see: cleaning validation protocols/reports, swab results, acceptance criteria and justifications.
Training and competency shortfalls
Typical wording: “Training records are incomplete or do not show competency for critical tasks.”
What they expect to see: up-to-date training matrix, competency checks, and on-the-job assessments.
CAPA program failures (ineffective or delayed corrective actions)
Typical wording: “Corrective actions are not timely, are not linked to root cause, or effectiveness checks are missing.”
What they expect to see: CAPA documentation, timelines, verification records.
Supplier qualification and incoming material control lapses
Typical wording: “Supplier qualification documentation is incomplete or incoming material acceptance lacks scientific justification.”
What they expect to see: supplier audit reports, CoAs, incoming test data, change history.
Change control not followed or not risk-assessed
Typical wording: “Changes implemented without adequate risk assessment, validation, or approvals.”
What they expect to see: change requests, risk assessments, impacted validation / testing.
Environmental monitoring excursions or aseptic deficiencies (sterile sites)
Typical wording: “Environmental monitoring trends show excursions without thorough investigation or remediation.”
What they expect to see: EM trend analysis, media fill reports, intervention logs, corrective actions.
Computerized system validation gaps
Typical wording: “CSV documentation is incomplete; system user access or backup controls are inadequate.”
What they expect to see: validation plans, test results, backup/restore logs, access control lists.
Labeling & packaging errors
Typical wording: “Label reconciliation or packaging controls are not adequate to prevent mix-ups.”
What they expect to see: label reconciliation records, packaging run records, and complaint follow-up.
How the QA team can proactively prepare — detailed step-by-step guide
(Do these steps once and then keep them as your playbook.)
Step 1 — Run the Atlas inspector profile
In Atlas Copilot, pull the inspector profile and copy their Top CFRs, Top observations, and typical document requests. Keep that list handy.
Step 2 — Map each top observation to real records at your site
For every observation in the inspector’s list, map:
Who owns the process (name/role)
The exact SOP(s) or protocol(s) that govern it
Where the records live (physical shelf, network folder, LIMS location, etc.)
Typical sample evidence the inspector will ask for
Make a simple spreadsheet with columns: Observation → Owner → Records to show → Location → Status.
Step 3 — Run focused micro-audits (inspector-style)
Use the inspector’s likely questions (Atlas will generate them) and ask for those exact documents.
If anything is missing, log it as a pre-CAPA with owner and due date.
Step 4 — Fix the quick wins immediately
Close missing signatures and dates.
Restore or export audit trails if missing.
Update SOP headers and version control fields.
Patch obvious housekeeping and labeling issues.
Step 5 — Build your Day-1 evidence pack (ready-to-hand)
Create a short folder (digital + one printed index) that contains:
Site overview, org chart, quality policy.
Validation master plan, recent validation/qualification reports.
Deviation/OOS trend summary and CAPA highlights.
Supplier list and recent audits.
CSV inventory and high-level validation status.
Label this as “Day-1 pack — for investigator requests.”
Step 6 — Rehearse roles and document flow
Assign host, scribe, document runners, and SME contacts.
Run a dry run of a 10-minute document request drill: request, locate, present, log.
Step 7 — Day-of inspection behavior
Be factual and concise. Show the exact record requested; avoid long narratives.
If a record is missing, show the mitigation and the plan to fix.
Keep a running log of what was shown and to whom.
Step 8 — If a 483 appears
Acknowledge receipt professionally.
Prepare a focused response that lists: root cause, immediate containment, corrective action, timeframe, and how you will verify effectiveness.
Inspections becoming tougher and more unpredictable in 2025, Atlas AI Copilot gives QA teams the insights and tools to stay prepared, avoid common observations, and ensure compliance. Start using Atlas today to make inspection readiness simple, proactive, and stress-free.”
Explore Atlas Compliance AI Copilot or schedule a demo to see how it can transform your inspection preparation.