Tag: PET Inspections

The FDA published it’s top 6 major issues for 2013/2014 as PET Inspections major issues in 2013/2014. Note how many of them are about records: Lack of adequate “Out of Specification” investigations Inadequate media fill validations, aseptic techniques and Environmental Monitoring Analytical assay methods not validated or verified for intended use Deficiencies in production and […]