UNIT 8: Regulatory Inspections, Observations & Compliance Unit Title
This unit explains how regulatory authorities conduct inspections and communicate compliance findings. It covers inspection outcomes such as FDA Form 483, Warning Letters, Deficiency Letters, and the role of CAPA. Also provides insight on ALCOA Principles
Definition
A regulatory inspection is a systematic examination conducted by health authorities to assess compliance with applicable regulations, guidelines, and commitments related to product quality, safety, and data integrity.
Inspections may be routine, for-cause, or pre-approval. Regulators evaluate facilities, processes, documentation, and personnel to verify that submitted data accurately reflects actual practices.
Key Points
Inspections verify compliance, not just documentation
Data integrity is a major inspection focus
Inspection outcomes directly impact approvals and supply
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