USFDA Audit Points/ Observations
USFDA Audit Points / Observations
1. Data Integrity & Documentation
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Missing or incomplete raw data (e.g., deleted chromatograms, overwritten results).
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Audit trails not reviewed or disabled in computerized systems.
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Backdating, overwriting, or unauthorized corrections in records.
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Use of unofficial/notebook records instead of controlled documents.
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Results not recorded contemporaneously.
2. Out-of-Specification (OOS) / Out-of-Trend (OOT) Handling
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Inadequate or incomplete OOS investigations.
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Failure to identify true root cause.
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Retesting done without documented scientific justification.
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Lack of QA involvement in OOS/OOT closure.
3. Laboratory Controls
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Incomplete instrument qualification (IQ/OQ/PQ).
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Equipment not calibrated or calibration overdue.
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Unapproved / outdated methods used for testing.
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System suitability tests not performed or not documented.
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Reference standards not properly qualified, labeled, or stored.
4. Stability Studies
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Stability chambers not qualified or monitored.
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Stability data missing or incomplete.
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Stability commitments to FDA not fulfilled.
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Inadequate investigation of stability failures.
5. Quality Management System (QMS)
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Incomplete deviation and CAPA management.
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Lack of trend analysis of deviations, OOS, complaints.
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Inadequate internal audits and self-inspections.
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Incomplete management review and follow-up actions.
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Change control not properly documented or evaluated for regulatory impact.
6. Manufacturing & Production
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Poor cleaning validation (residues, cross-contamination risks).
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Inadequate batch records (missing signatures, incomplete entries).
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Failure to follow approved Batch Manufacturing Record (BMR).
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Unqualified equipment used in production.
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Inadequate control of raw material dispensing and reconciliation.
7. Microbiology / Sterility
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Failure in environmental monitoring of sterile areas.
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HEPA filters not tested for integrity or leaks.
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Media growth promotion test (GPT) records missing.
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Poor aseptic practices by operators.
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Contamination incidents not investigated adequately.
8. Supplier & Raw Materials
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Vendor qualification incomplete or outdated.
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COAs from suppliers accepted without verification.
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Inadequate sampling procedures for incoming raw materials.
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Lack of traceability for raw materials and excipients.
9. Training & Personnel
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Inadequate or incomplete GMP training.
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Training records missing or not signed.
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Analysts/operators unable to explain SOPs they follow.
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Poor personnel hygiene or improper gowning practices.
10. Regulatory Compliance
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Failure to update methods/specifications to latest USP/ICH guidelines.
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Missing or incomplete regulatory submissions (variations, supplements).
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Failure to notify FDA of significant product quality issues.
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Repeat observations from previous FDA inspections not addressed.
✅ Key Point:
Most USFDA observations arise from Data Integrity failures, OOS mishandling, inadequate investigations, and poor documentation practices.
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