Inspection Consequences
Serious Deviations - Non Compliance
Depending on the seriousness of the deviation(s) found the consequences can include one or more of the following:
- Withholding the Good Laboratory Practice compliance statement so that on-going regulatory work cannot continue.
- A follow-up visit at a defined time to assess whether suitable investigation and action have been taken to bring the test facility back into compliance.
- Regulatory authorities rejecting a study or studies as invalid.
- Regulatory authorities subjecting additional studies from the test facility to more detailed review.
- Re-work may be necessary and registrations delayed significantly.
- Decreased confidence in the test facility and possible business failure.
- Legal action under national legislation can result in fines and/or imprisonment of personnel.
