FDA 483 - Asclemed USA Inc. dba Enovachem Pharmaceuticals - September 25, 2018

Asclemed USA Inc., dba Enovachem, a packer/repacker in Torrance, CA, received a Form 483 with three observations during an inspection from September 25-27, 2018. The observations primarily concern deficiencies in equipment calibration, lack of written procedures for annual product evaluations, and incomplete Certificates of Analysis for repackaged APIs. These issues indicate potential gaps in quality control and documentation practices.