Philip Kreiter
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Thomas W Nerney , Justine M Corson , Allison A Rodriguez , Mary-Jeanet Mcgarry , Slater K Bartlett , Debra M Emerson , Maya M Davis , Almaris N Alonso , Lauren M Lawrance , Pamela L Ogonowski , Rory Geyer , Douglas S Joslin , Pamela L Lee , Nichole B Murphy , Richard L Friedman , Amy C Jordan , Ashley M Whitehurst , Stacey S Degarmo , Ramon E Martinez
Detailed Analysis
Philip Kreiter’s approach can be summarized as meticulous, with an emphasis on product quality and sterility. He expects detailed documentation and strict adherence to FDA guidelines.
FDA investigator Philip Kreiter appears to have a strong focus on product quality, sterility, integrity, and the effective investigation of incidents. With multiple observations relating to product contamination, inadequate incident evaluation, insufficient sterilization validation, and uninvestigated potency discrepancies, it is clear that he values thoroughness and strict adherence to FDA guidelines in maintaining product quality and safety.
- Environmental Monitoring
- Contamination Control
- Facility Design
- Batch Release
- Sample Testing
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