Innscitech

If you are preparing for an audit, these are the "usual suspects" that end up on a 483:

1. Inadequate Investigations: Failure to thoroughly investigate any unexplained discrepancy or batch failure (the #1 most common finding).

2. SOP Non-compliance: Having written procedures but failing to follow them in practice.

3. Laboratory Controls: Lack of scientifically sound test procedures or data integrity issues.

4. Cleaning/Sanitation: Evidence of contamination or poor equipment maintenance.

5. Training: Lack of documented training for personnel performing critical tasks.

#483