FDA 483 - Institute of Applied Medicine, Inc - September 05, 2014

An FDA inspection of Institute of Applied Medicine, Inc. in Ishikari, Japan, a contract testing laboratory, revealed three significant observations. The firm failed to establish adequate written procedures for equipment cleaning based on validation, did not calibrate instruments at suitable intervals, and maintained incomplete laboratory records for microbial limit tests. These issues indicate deficiencies in quality control and data integrity practices.