FDA Forms Generally Used in Pharmaceutical Inspection
FDA Forms Generally Used in Pharmaceutical Inspection
1. Form FDA 482 – Notice of Inspection
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Issued at the start of an inspection.
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Notifies the company that FDA investigators are officially beginning the inspection under the authority of the FD&C Act (Section 704).
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Signed by the investigator and presented to site management.
2. Form FDA 483 – Inspectional Observations
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Issued at the end of the inspection if investigators observe potential violations of GMP or non-compliance.
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Lists specific conditions or practices that may violate the FD&C Act.
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Not a final agency action, but companies must respond with corrective actions within 15 working days.
3. Establishment Inspection Report (EIR)
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A detailed written report prepared after the inspection by the FDA investigator.
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Contains observations, evidence, discussions with company representatives, and overall inspection outcomes.
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A copy may be provided to the company after review by FDA headquarters.
4. Form FDA 484 – Receipt for Samples
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Issued when investigators collect product or raw material samples during the inspection.
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Confirms the type and quantity of samples taken for testing/analysis.
5. Form FDA 1571 – IND (Investigational New Drug Application)
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Used in clinical trial inspections.
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Sponsors must submit this form to FDA before beginning human trials.
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Reviewed during GCP (Good Clinical Practice) inspections.
6. Form FDA 356h – NDA/ANDA Submission Form
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Application form for New Drug Applications (NDA) or Abbreviated New Drug Applications (ANDA).
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Often inspected during pre-approval inspections (PAI).
7. Form FDA 483a – Extended Observations
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An attachment to FDA 483 used when additional space is required for recording multiple observations.
8. Warning Letters (Post-Inspection)
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Not a form but an official FDA enforcement action issued if 483 responses are inadequate.
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Communicates significant violations requiring prompt correction.
✅ Key Takeaway:
The most critical FDA forms in routine GMP pharmaceutical inspections are:
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FDA 482 (start of inspection),
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FDA 483 (inspectional observations),
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EIR (final report), and
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FDA 484 (sample receipt).
Others like FDA 1571 and 356h apply in specific contexts (clinical/approval inspections).
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