Miyoshi America, Inc – FDA 483, Jan 13, 2023

Miyoshi America, Inc. in Dayville, CT, an API manufacturer, was cited for three significant issues during an FDA inspection. The firm failed to establish adequate cleaning procedures to prevent cross-contamination, lacked sufficient control over computerized lab systems to prevent data deletion, and did not maintain complete laboratory control records for API release testing. These observations indicate deficiencies in quality control and data integrity practices.