What documentation failures are being highlighted in 2024–2025 FDA inspections?

From 2024–2025 FDA inspections the single biggest theme in documentation failures is data integrity and poor recordkeeping, including missing, incomplete, or altered records that undermine confidence in test results and release decisions. Other common documentation failures include incomplete batch records, inadequate deviation and CAPA documentation, poor electronic records controls (Part 11 gaps), weak supplier documentation, and insufficient training records. This article explains the specific documentation weaknesses the FDA is flagging, why inspectors focus on them, real-world examples and numbers from FDA datasets and warning letters, and an actionable remediation checklist that life-science and pharma manufacturers can implement now. This information is sourced from the Atlas Compliance tool. For more details, visit their website.

What documentation failures are being highlighted in 2024–2025 FDA inspections?

Regulatory inspections in 2024–2025 show a clear pattern: inspectors are increasingly focused on the trustworthiness of records. The FDA’s inspection tools and the public datasets it releases make it possible to see where citations keep appearing on Form FDA-483s and in warning letters. This matters because documentation is the documentary backbone of GMP. If records are weak or manipulated, product quality and patient safety are at risk. Below, I outline the top documentation failures observed, explain why they matter, show how inspectors are documenting their findings, and provide a practical remediation roadmap for pharma and life-science manufacturers.

Top documentation failures called out by FDA inspectors (2024–2025)

1) Data integrity failures (most frequent, highest impact)

What inspectors are seeing:

• Missing raw data, gaps in audit trails, or evidence of manual deletion/overwriting.
• Electronic systems without secure access controls or unreviewed audit trails.
• Laboratory notebooks, instrument printouts, and electronic records that contradict each other or are incomplete.

Why this is flagged: Data integrity undermines the reliability of test results, stability studies, and release decisions. The FDA has repeatedly emphasized the integrity of records as critical in warning letters and recent inspection summaries. Industry analyses and recent warning letters in 2024–2025 repeatedly list data integrity as a primary cause for enforcement actions.

2) Incomplete or inaccurate batch production and control records

What inspectors are seeing:

• Missing signatures or dates on batch records.
• Discrepancies between electronic entries and paper documents.
• Unexplained blanks, late entries, or overwrites without proper justification.

Why this is flagged: Batch records are the legal proof that production followed approved procedures. Incomplete batch records make it impossible to reconstruct what happened during a production run and to assess whether a product meets specifications. The FDA’s inspection datasets continue to show high citation counts for CFRs related to written procedures and batch records.

3) Poor laboratory documentation and OOS/OOT investigations

What inspectors are seeing:

• Missing lab raw data for assays or stability tests.
• Inadequate documentation of out-of-specification (OOS) and out-of-trend (OOT) investigations, superficial reports that do not address the root cause.
• Failure to retain original chromatograms, spectra, or instrument files.

Why this is flagged: Laboratories generate the data that support product release. If labs cannot provide original data or robust investigations of OOS results, the reliability of product testing is compromised, and recalls or warning letters can follow. Recent FDA letters cite incomplete lab records and poor investigation quality as recurring themes.

4) Electronic records and 21 CFR Part 11 compliance gaps

What inspectors are seeing:

• Lack of system validation, weak user access management, or absence of secure, time-stamped audit trails.
• Failure to demonstrate that electronic signatures are tied to record content and user identification.

Why this is flagged: As systems move digital, regulators require that electronic records be as trustworthy as paper ones under Part 11. Many inspections find implementation gaps, unvalidated systems, missing SOPs for electronic controls, and inadequate electronic record retention. The FDA’s inspectional citations database and Part 11 guidance remain key references inspectors use.

5) Inadequate deviation, CAPA, and change control documentation

What inspectors are seeing:

• Deviations documented but not investigated to the root cause.
• CAPAs that lack measurable corrective actions, timelines, or verification.
• Change control requests filed without complete justification or impact assessment.

Why this is flagged: Deviations and CAPAs are how a quality system learns and improves. When documentation is weak, systemic problems persist, and similar errors repeat. The FDA frequently flags CAPA systems in warning letters when documentation shows ineffective problem resolution.

6) Supplier and incoming material documentation gaps

What inspectors are seeing:

• Supplier qualification files are missing audit reports or certificates of analysis (CoAs).
• Inadequate documentation of incoming material testing or unexplained acceptance of out-of-spec supplier lots.

Why this is flagged: External suppliers can introduce risk. If supplier documentation is incomplete, the manufacturer cannot demonstrate that inputs meet specifications. Inspectors look for full traceability purchase orders, CoAs, sampling records, and supplier audits.

7) Training and personnel records lacking evidence of competency

What inspectors are seeing:

• Training logs without evidence of assessment or practical demonstration of competency.
• SOP revisions implemented without training records dated before the change rollout.

Why this is flagged: Competent personnel are central to consistent GMP execution. Documentation that training occurred and that it was effective is required. Inspectors cite companies where training records are missing or superficial.

8) Stability study and retention sample documentation deficiencies

What inspectors are seeing:

• Missing chain-of-custody for retention samples.
• Incomplete stability data files, missing raw chromatograms, or inconsistent sample labeling.

Why this is flagged: Stability records support expiry dating and product claims. Gaps can lead to regulatory actions and product recalls. Inspectors are especially strict when stability data cannot be independently verified.

How FDA inspectors document these failures (and where to look)

Inspectors record their observations in Form FDA-483s and, where applicable, in Warning Letters and Establishment Inspection Reports (EIRs). The FDA publishes inspectional observations and provides spreadsheets summarizing counts by regulatory area (available on the FDA site). These public sources display the frequency of citations per CFR reference and reveal trends, such as recurring citations related to data integrity, laboratory controls, and written procedures. For practitioners, the FDA’s inspection observations page and the “Inspectional Observations and Citations” guidance are primary sources to understand what is being cited and why.

Evidence from 2024–2025 enforcement actions and industry analyses

• The FDA’s dashboards and FOIA reading room indicate a steady stream of Form FDA-483 observations related to records, data integrity, and laboratory controls in 2024 and into 2025. These datasets enable you to count the number of times specific citation codes are used across inspections.
• Industry reports and compliance blogs analyzing 2024–2025 warning letters highlight data integrity as the leading root cause in recent enforcement letters; incomplete lab records, manipulated data, and inadequate electronic systems figure prominently. These analyses synthesize public warning letters and 483 observations to show that data-related failures remain the most visible and consequential documentation problems.

Why documentation failures keep happening, the underlying causes

1. Digitization without controls — Many firms moved to electronic systems quickly but didn’t complete validation, access controls, and SOPs that make electronic records trustworthy.
2. Poor quality culture — Documenting problems takes time; where production pressure dominates, staff may shortcut documentation or delay entries.
3. Legacy hybrid systems — Mixed paper/electronic systems create gaps, for example, a test instrument saves files electronically, but the laboratory’s SOPs still rely on paper notebooks.
4. Weak root-cause investigations — Superficial investigations produce superficial CAPAs that don’t prevent recurrence, and this shows up in documentation as incomplete or placeholder reports.
5. Supplier oversight blind spots — Firms accepting supplier CoAs without qualification audits or failing to maintain supplier audit documentation create downstream record risks.

These root causes explain why inspectors repeatedly find very similar documentation failures across firms and geographies.

Inspector’s perspective, what they look for in documentation

Inspectors are trained to validate:

• Completeness — Are all raw data files present for the period under review?
• Traceability — Can each entry be mapped to a responsible person and a time?
• Authenticity — Is there evidence of alteration, deletion, or back-dating?
• Adequacy of investigation — For deviations or OOS results, did the firm do a thorough root cause analysis and verify effectiveness?
• System controls — Are electronic systems validated, and are audit trails reviewed periodically?

If records are incomplete or look altered, an inspector will expand the review, often pulling more datasets and interviewing staff to understand whether the issue is a single error or a systemic failure. The FDA’s citation framework and inspector manuals guide this work; practitioners should expect inspectors to use system-generated audit trails, instrument logs, and cross-checks between systems.

Real-world examples and numbers (what the public records say)

• The FDA’s inspectional data pages list counts of citations by area for fiscal years; those spreadsheets show patterns where citations for written procedures, laboratory controls, and recordkeeping continue to appear frequently on Form FDA-483s in 2024 and 2025. Referencing the FDA’s inspection observations page is the best way to extract the specific counts for your product area and fiscal year.
• Several public warning letters in 2024–2025 explicitly cite missing lab raw data and inadequate OOS investigations. These letters provide concrete case studies that compliance teams can study to better understand what triggered enforcement and what the FDA required for remediation. Industry summaries of those warning letters confirm that data integrity accounts for a high share of serious citations.

Practical remediation: documentation controls that reduce inspection risk

Here is a prioritized, inspector-focused remediation plan teams can implement.

Quick wins (0–3 months)

• Block future overwrites: Immediately restrict system write/delete privileges to the minimum necessary users and enable immutable audit trails where possible.
• Stop the clock: Enforce a policy of contemporaneous entries (no back-dating), with training and supervisor spot checks.
• Document storage: Centralized storage of raw lab data (instrument files, chromatograms) in a validated, access-controlled repository.
• Training catch-up: Ensure training records are updated and include evidence of competency (signed assessments).

Medium term (3–9 months)

• System validation: Validate key systems per validation lifecycle (IQ/OQ/PQ), and retain validation artifacts in a searchable location.
• Audit trail reviews: Create documented periodic reviews of audit trails (who reviewed, findings, actions) for critical systems.
• CAPA strengthening: Revise CAPA procedures to include measurable actions, owners, due dates, and verification steps.
• OOS procedure overhaul: Ensure the OOS procedure requires preservation of raw data, thorough root cause analysis, and documented verification of corrective actions.

Long term (9–18 months)

• Quality culture program: Implement leadership-driven quality culture initiatives that incentivize right-first-time documentation and truthful reporting.
• Supplier governance: Build a supplier file library (audits, CoAs, change notifications) and conduct periodic supplier risk reviews.
• Digital transformation strategy: Move to integrated, validated systems with clear data flows and single sources of truth to avoid hybrid system mismatches.

Practical checklist: inspector-ready documentation (what to have when an inspector asks)

• Batch records: complete, signed, dated, with explanations for any deviations.
• Raw lab data: instrument files, chromatograms, printouts, analyst notebook pages, and electronic files.
• Audit trails: system-generated logs for critical systems with documented periodic review.
• OOS/OOT files: full investigation package, raw data, review notes, root cause analysis, CAPA, verification.
• Validation packages: complete IQ/OQ/PQ and change control history.
• Supplier files: CoAs, audit reports, quality agreements.
• Training records: dated, signed, and matching SOP versions.
• Retention sample chain-of-custody and stability data.

How to perform a documentation gap assessment (step-by-step)

1. Scope & prioritize: Identify critical systems (laboratory LIMS, MES, ERP, chromatography systems) and highest impact documents (release testing, stability, batch records).
2. Sample retrieval test: Randomly pick recent batches and attempt to reconstruct the batch and lab history from available records, noting any gaps.
3. Audit trail verification: Pull audit trails and match them against human entries; investigate any inconsistencies.
4. OOS file deep dive: Select any OOS reports from the previous 12 months and evaluate investigation depth and CAPA effectiveness.
5. Supplier file audit: Confirm supplier CoAs, audit reports, and deviation histories for high-risk suppliers.
6. Report & remediate: Create an action plan with owners and due dates and track to closure.

This exercise mimics what an FDA inspector will do and hence prepares teams to find and fix issues before an inspection.

Communicating with inspectors: best practices

• Be transparent: Acknowledge issues, explain corrective actions, and provide documentation promptly.
• Avoid defensive language: Stick to facts and provide the documentary trail.
• Use concise summaries: Provide a one-page chronology for complex issues (what happened → root cause → corrective actions → verification).
• Ensure SMEs are available: Have subject matter experts (QA, lab manager, IT) ready to explain systems and records.

Inspectors expect firms to be proactive and to have credible, evidence-backed remediation; vagueness or evasiveness raises regulatory risk.

Closing the business case for fixing documentation now

Documentation failures are not just regulatory nuisances; they are business-critical risks. Poor records cause product holds, recalls, delays in approvals, loss of market access, and reputational damage. Investing in robust documentation practices, validated electronic systems, and a quality culture protects patients and the company’s bottom line.

To summarize: in 2024–2025, the FDA is emphasizing data integrity, complete batch and lab records, and effective CAPA/deviation documentation. These are the documentation areas that produce the most serious inspection outcomes, and they are fixable with disciplined process changes, IT controls, and consistent leadership support.

Most frequently asked questions related to the subject.

Q1 — What is the single most common documentation citation on Form FDA-483 in 2024–2025?
A1 — Data integrity and recordkeeping (missing or incomplete raw data, audit trail issues) top the list. Public FDA inspection spreadsheets and warning letters confirm this trend.

Q2 — How does the FDA define data integrity concerns?
A2 — The FDA expects records to be ALCOA(+): Attributable, Legible, Contemporaneous, Original, Accurate — plus Complete, Consistent, Enduring, and Available. Deviations from these principles trigger scrutiny.

Q3 — Will digitizing records automatically reduce inspection risk?
A3 — Not unless systems are validated, access is controlled, audit trails are enabled and reviewed, and SOPs are updated. Poorly implemented digitization can increase risk.

Q4 — How long should we retain raw lab data and batch records?
A4 — Retention timelines depend on product type and regulations (for example, 21 CFR guidance for drugs), but manufacturers should follow their regulatory retention policy and ensure records are quickly retrievable during inspections. FDA guidance and inspection reports expect demonstrable traceability.

Q5 — Can you summarize a 6-point action plan to reduce documentation citations?
A5 — Yes: 1) Lock down electronic access and enable audit trails; 2) Validate critical systems; 3) Centralize raw data storage; 4) Strengthen OOS/CAPA procedures; 5) Improve training records and competency evidence; 6) Run internal inspection-style audits and remediate promptly.