FDA 483 - Immacule Lifesciences Private Limited - June 20, 2022

Immacule Lifesciences Private Ltd. India received an FDA Form 483 with eight observations, highlighting significant deficiencies in aseptic processing, quality control, and environmental monitoring. The firm failed to maintain adequate environmental controls during power outages, did not adhere to its stability testing program, and exhibited issues with quality control unit procedures and testing method suitability. Additionally, there were concerns regarding microbiological contamination prevention and continuous temperature monitoring for active pharmaceutical ingredients.