What are the various steps involved in USFDA Audit:-

The US FDA (Food and Drug Administration) audit process involves the following steps:

1. *Pre-Audit*: Notification of audit, review of company records, and preparation.

2. *Opening Meeting*: Introduction, audit purpose, scope, and procedures.

3. *Audit*: Review of documents, records, and processes; interviews with personnel.

4. *Inspection*: Observation of facilities, equipment, and operations.

5. *Sampling*: Collection of product samples for testing (if applicable).

6. *Closing Meeting*: Discussion of findings, observations, and recommendations.

7. *Audit Report*: Written report detailing findings, deviations, and corrective actions.

8. *Response*: Company response to audit report, addressing deviations and corrective actions.

9. *Follow-up*: FDA review of company responses and verification of corrective actions.

10. *Classification*: Audit classification (e.g., No Action Indicated, Voluntary Action Indicated, Official Action Indicated).

11. *Compliance*: Implementation of corrective actions and ongoing compliance.

Note: The FDA may also conduct follow-up audits to ensure compliance.