How to Prepare for a FDA Inspection
⚠️ 5 Most Common FDA 483 Observations in Pharma
1. Inadequate Investigations (OOS / Deviations / Complaints)
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Failure to thoroughly investigate out-of-specification (OOS) results, deviations, or complaints.
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Root cause analysis either incomplete, unjustified, or not performed.
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CAPA not implemented or verified for effectiveness.
2. Poor Documentation Practices (Data Integrity Violations)
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Records not completed contemporaneously (backdating, missing entries).
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Missing or altered raw data (manual or electronic).
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Lack of secure audit trails in computerized systems.
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Failure to follow ALCOA+ principles.
3. Inadequate Cleaning & Cross-Contamination Controls
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Cleaning validation not scientifically justified.
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Residues found on “clean” equipment.
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Ineffective cleaning verification or lack of swab/rinse testing.
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No dedicated equipment for high-risk drugs (penicillin, hormones, cytotoxics).
4. Laboratory Controls Deficiencies
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Analytical methods not validated.
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Incomplete raw data (chromatograms, worksheets).
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Failure to properly review laboratory results.
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Inadequate microbiological controls (sterility, endotoxin, EM programs).
5. Failure of Quality Unit (QA) Responsibilities
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Quality Assurance not exercising proper oversight.
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Batch records released without complete review.
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Inadequate change control, training, or supplier qualification.
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QMS not effectively implemented.
📌 Key Takeaway
Most FDA 483s highlight systemic weaknesses in:
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Investigations (OOS, deviations)
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Data integrity & documentation
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Cleaning/contamination control
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Laboratory practices
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Quality Unit oversight
By strengthening these core areas, companies can reduce inspection risk and improve compliance.
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