FDA 483 - Miami University - November 05, 2021

This FDA Form 483 details significant deficiencies at Miami University's control testing laboratory in Oxford, OH, following an inspection from November 1-5, 2021. The firm was cited for a complete lack of a Quality Control Unit and written procedures, severe data integrity issues including manipulation of test results, inadequate training, and uncalibrated equipment. These observations indicate a fundamental breakdown in GMP compliance for API Heparin Sodium, USP testing.